Fda regulatory jobs in Hoboken, New JerseyCreate job alerts

The Graphic Designer is responsible for executing high-quality packaging, print, and digital design initiatives that support Overseas Food Trading’s expanding global product portfolio. This role combines creative development with technical production expertise to ensure visually compelling, production-ready materials that align with brand standards, regulatory requirements, and commercial objectives. The position supports cross-functional departments, including Sales, Marketing, Product Development, Compliance, and Logistics, ensuring that all creative assets are delivered accurately, efficiently, and within established timelines. The Graphic Designer plays a key role in maintaining brand consistency, supporting product launches, and contributing to the company’s continued growth in both retail and foodservice sectors. This role requires effective collaboration with internal stakeholders and external print vendors. The individual must be comfortable working in a fast-paced environment where priorities may shift and must respond with flexibility, professionalism, and structured follow-through. ESSENTIAL JOB FUNCTIONS Creative Development & Design Execution • Develop compelling packaging, product labels, marketing collateral, and digital assets that effectively showcase the company’s global product portfolio., • Execute design projects from initial concept through final production, ensuring alignment with brand standards and commercial objectives., • Translate product positioning and sales strategies into visually engaging creative solutions., • Maintain consistency across multiple brands while adapting designs to category-specific requirements., • Contribute creative ideas during team brainstorming sessions and design reviews while remaining receptive to direction and feedback. Packaging Production & Technical File Preparation • Prepare production-ready artwork files in accordance with printer specifications, dielines, and regulatory labeling requirements., • Ensure proper setup of bleeds, color profiles, trapping, typography, and layout accuracy for print production., • Create accurate mockups and renderings for internal review, sales presentations, and customer approvals., • Coordinate proof reviews and revisions to maintain quality control prior to final release., • Communicate directly with print vendors and external production partners to confirm technical specifications and production timelines. Project Management & Workflow Coordination • Manage multiple concurrent projects while maintaining high standards of quality and meeting established deadlines., • Proactively prioritize workload based on shifting business needs and launch timelines., • Support Senior Graphic Designer and team members during peak periods to ensure departmental efficiency., • Maintain organized digital file structures, version control, and archived assets for long-term accessibility., • Track project progress and follow through to completion with structured organization and accountability. Cross-Functional Collaboration • Collaborate closely with Sales, Marketing, Product Development, and Compliance to ensure design solutions align with regulatory standards and commercial objectives., • Incorporate stakeholder feedback efficiently while maintaining design integrity and visual clarity., • Support product launches by ensuring all creative materials are completed accurately and delivered on schedule., • Assist in resolving design-related production issues through clear communication and solution-oriented problem solving. Continuous Improvement & Brand Support • Stay current with packaging trends, print technologies, and food industry design standards., • Identify opportunities to enhance workflow efficiency and creative processes within the Design Department., • Contribute to the ongoing elevation of brand presentation across retail and foodservice channels. PERFORMANCE EXPECTATIONS • Demonstrate strong ownership and accountability for assigned design projects from concept through production release., • Consistently deliver high-quality, production-ready artwork that meets brand standards, regulatory requirements, and technical specifications., • Maintain accuracy and attention to detail, minimizing revisions caused by preventable errors., • Effectively manage multiple concurrent projects while meeting established deadlines in a fast-paced environment., • Exhibit professionalism and flexibility when priorities shift or urgent requests arise., • Maintain organized digital file systems and documentation to support team efficiency and long-term asset management., • Communicate clearly and collaborate effectively with internal departments and external vendors., • Contribute positively to team morale by supporting colleagues during high-volume periods and participating constructively in feedback sessions., • Demonstrate initiative in identifying workflow improvements and creative enhancements. Education and Experience: • Bachelor’s degree in Graphic Design or related field required., • A minimum of 3 years of professional graphic design experience, preferably in packaging, print production, or food/CPG industries., • Demonstrated experience preparing production-ready artwork files for commercial print., • Experience collaborating cross-functionally within a structured business environment preferred. Knowledge and Skill Requirements/Specialized Courses and/or Training: • Strong foundation in design principles including layout, typography, color theory, and visual hierarchy., • Advanced proficiency in Adobe Creative Suite (Illustrator, Photoshop, InDesign, Acrobat)., • Advanced Photoshop capabilities, including photo manipulation, retouching, and product renderings., • Solid understanding of packaging mechanics, dielines, labeling requirements, and print production processes., • Knowledge of color management, prepress preparation, and technical file setup for commercial printing., • Ability to manage multiple projects and shifting priorities with structured organization and attention to detail., • Strong problem-solving skills with the ability to troubleshoot production-related issues., • Working knowledge of FDA labeling standards or food packaging compliance requirements is a plus. Language and Communication Skills: • Strong written, verbal, and interpersonal communication skills., • Ability to clearly articulate design concepts, creative rationale, and technical requirements to internal stakeholders and external vendors., • Effective collaboration with cross-functional departments including Sales, Marketing, Product Development, Compliance, and Logistics., • Ability to interpret and incorporate feedback efficiently while maintaining professionalism and design integrity., • Clear and professional communication when coordinating with print vendors regarding specifications, proofs, revisions, and production timelines., • Strong listening skills and openness to constructive critique in a collaborative team environment. Physical, sensory, and motor demands: Frequent standing and sitting. Intermittent squatting, bending, twisting, lifting. This position requires excellent visual acuity and auditory sense. The noise level in the work environment is usually quiet.

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. As we continue to grow as one QuidelOrtho we are seeking a Program Lead, Digital Informatics QMS Strategy. This Program Lead is responsible for developing, maintaining, and communicating QuidelOrtho' s Quality Management System strategy for Digital Informatics, Software as a Medical Device (SaMD), Artificial Intelligence (AI/ML), and Automation platforms as they pertain to in vitro diagnostic (IVD) products and associated services across all global markets. This role serves as the strategic quality authority for digitalenabled products, ensuring that regulatory, quality, and compliance expectations are proactively embedded into product lifecycle processes, digital delivery models, and organizational ways of working. This position will be onsite in Rochester, NY. * Define and evolve the global QMS strategy for digital health technologies, including SaMD, AI/MLenabled systems, cloudbased platforms, and automated workflows. * Interpret and operationalize global regulatory and standards requirements (e.g., FDA, EU MDR/IVDR, ISO 13485, IEC 62304, ISO 62366, ISO 14971, GxP data integrity) as they apply to digital and informatics solutions. * Partner with R&D, IT, Product Management, Regulatory Affairs, PMO, and Technical Quality to ensure quality by design is embedded throughout the digital product lifecycle. * Establish governance models, procedural frameworks, and decision pathways that enable agile and scalable digital innovation while maintaining regulatory compliance. * Lead riskbased approaches for software lifecycle management, cybersecurity, data governance, AI/ML change control, and algorithm performance monitoring. * Serve as a thought leader and internal consultant on emerging regulatory expectations related to AI/ML, realworld data, automation, and digital transformation. * Perform other work-related duties as assigned. Required: * Bachelors and/or technical degree in Life Sciences, Pharmacy, Engineering, Computer Science, Biomedical Engineering or a related technical discipline. * 8-10 years of progressively responsible experience within a regulated Quality Management System environment, with significant exposure to software, digital health, or informatics solutions. * Demonstrated ability to lead QMS strategy development and influence senior stakeholders across complex, matrixed organizations. * Strong understanding of global regulatory frameworks applicable to digital health, SaMD, AI/ML, and automated systems. * Proven experience applying risk management, design controls, software lifecycle processes, and post market surveillance to digital products. * Ability to translate regulatory and quality requirements into practical, scalable processes that support innovation. * Bias toward action, with a track record of driving execution aligned to organizational strategy. * Excellent written and verbal communication skills, including the ability to represent quality positions to executive leadership. * Strong collaboration skills and the ability to operate effectively across technical, regulatory, and business functions. * Willingness and ability to travel approximately 10-15%. Preferred: * Advanced degree (MS, PhD, or PharmD) strongly preferred. * Experience with AI/ML governance, algorithm change management, or real-world performance monitoring. * Background in cloudbased systems, cybersecurity, data integrity, or regulated automation platforms. * Experience supporting global regulatory inspections involving software or digital health products. Internal: Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, GSO, Quality & Compliance teams globally and regionally. External: Regulatory agencies, Notified Bodies, Contract manufacturers, Suppliers, and service providers. The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment. No strenuous physical activity. Standard activities include sitting, standing, walking, talking, hearing, and visual work. May include occasional travel for site visits, leadership meetings, or regulatory support. At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they're essential to how we thrive as a team and achieve meaningful impact: * Thrive Together - Collaborate intentionally, grow as a team * Make It Happen - Focus on priorities, embrace continuous improvement * Commit to Service - Cultivate a service mindset * Embrace Inclusion - Be open and authentic, welcome diverse perspectives Salary range for this position takes into account a wide range of factors including: education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. Salary range for this position is $155,000 to $202,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at ___. #LI-SP1

We are looking to add a Senior Clinical Research Coordinator to a growing team with lots of room for growth. This is a full time, permanent onsite position that comes with full benefits, PTO etc. Relocation or Sponsorship will not be offered at this time. Position Summary The Senior Clinical Research Coordinator (SCRC) is responsible for the planning, coordination, and execution of clinical research studies in compliance with regulatory requirements, institutional policies, and study protocols. This role provides advanced coordination of multiple clinical trials, ensures high-quality data collection, supports regulatory submissions, and may mentor junior research staff. Key Responsibilities • Coordinate and manage all aspects of assigned clinical trials from start-up through closeout., • Ensure study conduct follows protocol, Good Clinical Practice (GCP), and regulatory guidelines., • Schedule and oversee study visits, procedures, and participant follow-up., • Maintain study timelines, enrollment targets, and protocol compliance., • Prepare and submit regulatory documents to Institutional Review Boards (IRB), sponsors, and regulatory agencies., • Maintain regulatory binders and essential study documentation., • Ensure adherence to FDA, ICH-GCP, and institutional requirements., • Screen, recruit, and consent study participants., • Educate participants about study procedures, risks, and benefits., • Monitor participant safety and report adverse events according to protocol., • Collect, review, and enter clinical trial data into electronic data capture systems (EDC)., • Resolve data queries and ensure accuracy and completeness of study records., • Maintain source documentation and case report forms (CRFs)., • Serve as primary contact for sponsor and CRO monitors., • Prepare for site visits, monitoring visits, and audits., • Address findings and implement corrective actions when needed., • Provide training and guidance to junior clinical research coordinators and support staff., • Assist with study feasibility assessments and site start-up activities., • Contribute to process improvements and research program development. Education • Bachelor’s degree in Life Sciences, Nursing, Public Health, or related field required, • Master’s degree preferred Experience • 4–7+ years of clinical research coordination experience, • Experience managing multiple clinical trials preferred, • Experience with regulatory submissions and monitoring visits Certifications (Preferred) • CCRC (Certified Clinical Research Coordinator) – ACRP, • CCRP (Certified Clinical Research Professional) – SoCRA Skills & Competencies • Strong knowledge of ICH-GCP, FDA regulations, and clinical trial processes, • Excellent organizational and project management skills, • Strong attention to detail and documentation practices, • Ability to manage multiple studies simultaneously, • Effective communication and interpersonal skills, • Proficiency in EDC systems, CTMS, and Microsoft Office

Responsible for receipt and documentation of Safety information for Marketed and Investigational Products. Interacts with health professionals and consumers to obtain and follow-up reports of possible adverse events with company products. Provides product information to health care professionals, consumers, and sales representatives. Codes and enters information into the global safety database. Verifies the accuracy, completeness and validity of information for each adverse event report for which he/she is responsible. Assures consistency of case records and documentation. Creates and ensures distribution of regulatory reports for FDA and other regulatory health authorities. Accurate and timely data entry of both domestic and foreign adverse event and serious adverse event information into the PSSS (Product Safety Surveillance System) consistent with the ARISg coding manual, SOPs/WIDs, process flows and established time frames within the ARISg workflow. Full understanding of the products’ company Core Data sheet, PI, and/or IB for accurate labeling and listedness. Perform appropriate and timely follow-up per department guidelines, including accurate and thorough communication documentation within the case. Maintain proficiency in the utilization of the PSSS, including MedDRA coding. This may include participating in the validation process for the PSSS. Ensure accurate and timely submissions to regulators, co-marketing partners and affiliates within company and regulatory timeframes. Utilize ARISg for all reporting and confirmation of successful distribution and acknowledgement. Maintain sufficient knowledge of all company products to ensure professional and knowledgeable discussions with consumers and healthcare providers and dissemination of accurate product information in response to queries. Provide high level customer service to consumers, health care professionals and internal customers. Complete all required training within the timelines provided so as to ensure knowledge of all relevant corporate and departmental SOP’s, SWP’s and WID’s. Ensure timeliness in regulatory compliance Gather sufficient information to assess the medical significance of an adverse event report, while at the same time assuring the information provided adequately addresses the concerns of the health care provider and/or consumer. Required Qualification & Skills: Bachelor’s degree in Medical field with RN or RPh licensure, or PharmD/MD degree required. Minimum 2 to 4 years in industry application of clinical medicine/pharmacy with a minimum of 1 year in pharmaceutical drug safety Experience in verbally interviewing and/or providing medical information to health care professionals and consumers Application of clinical medicine to patient care Medical terminology and standards of patient care Computer proficiency

Mama’s Creations, Inc. (NASDAQ: MAMA) is a leading marketer and manufacturer of fresh deli prepared foods, found in over 8,500 grocery, mass, club and convenience stores nationally. The Company’s broad product portfolio, born as MamaMancini’s, from a rich history in Italian foods, now consists of a variety of high quality, fresh, clean and easy to prepare foods to address the needs of both our consumers and retailers. Our vision is to become a one-stop-shop deli solutions platform, leveraging vertical integration and a diverse family of brands to offer a wide array of prepared foods to meet the changing demands of the modern consumer. For more information, please visit . We have an excellent opportunity for a highly skilled and experienced leader to serve as the Senior Director, Plant Operations of our East Rutherford facility. You will be the senior site leader responsible for the overall performance, safety, Grandma Quality, controls, culture, and financial results of the manufacturing facility. This role serves as the plant’s general manager, accountable for translating enterprise strategy into consistent, disciplined execution with excellence at the site level. The Senior Director leads through people, systems, and standards, ensuring production, FSQA, maintenance, warehousing, and workforce leadership operate in alignment with Grandma Quality. This role balances results with responsibility, honoring Mama’s heritage while building scalable, sustainable operations. Key Responsibilities • Own end-to-end plant performance, including safety, food safety, quality, service, cost, labor efficiency, and employee engagement., • Own overall plant efficiency and throughput performance, ensuring production capacity, labor models, and operating practices support enterprise targets., • Drive improvement in throughput, yield, and line performance by setting expectations, removing barriers, and holding leaders accountable for results., • Serve as the strategic leader for the site, translating enterprise priorities into clear site-level strategies, initiatives, and execution plans., • Partner with the Senior Manager, Production Operations to ensure production schedules and execution plans support optimal efficiency and service outcomes., • Own the plant operating budget, including labor, overtime, supplies, and controllable costs; ensure performance aligns with financial targets., • Balance cost discipline with Mama’s commitment to Grandma Quality, safety, and employee well-being., • Use KPIs and financial data to evaluate performance, prioritize investments, and guide decision-making., • Partner with OpEx/CI to identify and sponsor continuous improvement initiatives that deliver measurable, sustainable gains in efficiency, throughput, and cost performance., • Ensure efficiency gains and cost improvements are sustainable and embedded into standard work and leadership routines., • Lead, coach, and hold accountable all direct reports, site functional leaders, and the downline., • Serve as the primary owner of plant culture, reinforcing values-based leadership, respectful supervision, and consistent accountability., • Ensure site execution aligns with enterprise standards of excellence and Grandma Quality while addressing location-specific risks and opportunities., • Partner with FSQA leadership to maintain strong food safety culture, regulatory compliance, and audit readiness., • Own site-level labor strategy, workforce planning, and performance management in partnership with People Operations., • Drive operational discipline through KPIs, operating practices, and structured problem-solving., • Partner with Reliability & Asset Management to support uptime, preventive maintenance execution, and capital improvements., • Support capital projects, expansions, and equipment installations at the site level., • Participate in operational diligence and integration activities related to acquisitions or expansions impacting the facility., • Serve as the primary escalation point for site risks, performance gaps, and employee relations matters., • Build strong cross-functional relationships that nurture trust, accountability, and pride in workmanship., • Collaborate closely with Senior Directors and plant leaders at other facilities to share best practices, standardize where appropriate, and drive enterprise-wide operational improvement., • Participate in cross-facility working groups, initiatives, and problem-solving efforts to strengthen consistency, performance, and scalability across the enterprise., • Champion collaboration between facilities while respecting site-specific strengths, constraints, and heritage., • Other related tasks, as necessary to drive results and support the business. Qualifications • Bachelor’s degree in Operations Management, Engineering, Business, or related field; or equivalent experience., • 15+ years of progressive leadership experience in manufacturing operations, preferably in food manufacturing or regulated environments., • 10+ years of experience leading multi-shift operations and managing leaders (managers/supervisors)., • Demonstrated experience owning site KPIs, budgets, labor planning, and operational performance improvement., • Expert usage of ERP systems. NetSuite preferred., • Strong working knowledge of food safety/regulatory environments (USDA/FDA), HACCP, GMPs, and audit readiness expectations., • Proven ability to lead through change while maintaining operational stability and culture., • Strong communication, planning, and cross-functional leadership skills., • Lean/Six Sigma knowledge/certification, preferred., • Bilingual (English/Spanish) highly preferred. Essential Physical Requirements • Ability to regularly walk, stand, and move throughout the manufacturing facility., • Ability to navigate stairs, catwalks, and uneven surfaces safely., • Ability to visually and audibly observe operations and employee practices., • Ability to wear required PPE (hair/beard nets, safety shoes, gloves, safety glasses, hearing protection)., • Ability to work in varying environmental conditions (heat, cold, noise, humidity)., • Ability to sit for extended periods while performing administrative work., • Ability to travel locally as required., • Ability to communicate clearly and effectively. We offer a comprehensive compensation package that includes a base salary (to $185k,) plus bonus eligibility, paid time off, holiday pay, medical, dental, vision, and life insurances, FSA, EAP, and 401(k.) Applicants should submit a resume to for immediate consideration.

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. QuidelOrtho is seeking a Manager, Data Analytics. The Manager, Data Analytics is a global people leader within QuidelOrtho' s Global Quality & Compliance (GQ&C) organization. This leader is responsible for developing and leading a team of Quality professionals to ensure the design, implementation, and continuous improvement of Quality systems, processes, and programs that enable QuidelOrtho' s Right to Operate and support business agility, innovation, and growth. This role provides strategic direction and operational oversight across Quality disciplines. operate under little to no direct supervision and provide independent guidance to the business. This position is considered a subject matter expert in Quality Data Analytics and Complaint Trending. They are accountable for the work of the Quality Data Analytics team and the success of team projects; and will have significant amounts of critical organizational and technical knowledge. This leader is responsible for the day-to-day management and supervision of Quality Engineers and Data Analysts and is also accountable for developing talent, strengthening scientific and compliance capabilities, and fostering a culture of engagement, collaboration, and performance. By integrating technical expertise, data-driven insights, and agile leadership behaviors, the Manager, Data Analytics ensures that Quality systems and teams deliver sustainable business and compliance outcomes. This position will be Hybrid in any global QuidelOrtho site. * Provides independent guidance to business partners on quality data handling and analytics. Establish dashboards and data visualizations to support product quality and continuous improvement. * Leads metrics and data analytics work for Complaints, Recalls, NC, CAPA, Audits/Compliance and other areas of Quality. * Ability to manage complaint trending activities and related software system validations * Ability to compile and present quality data and analysis to the business eg: Management Review. * Lead, develop, and inspire a team of Quality professionals to achieve organizational and individual performance objectives. * Establishclear priorities, assign responsibilities, and ensure effective resource allocation to meet business and compliance needs. * Provide technical, regulatory, and operational leadership to ensure Quality systemscomply withISO 13485, FDA 21 CFR 820, IVDR, and other applicable requirements. * Drive harmonization and standardization of Quality processes, procedures, and tools across sites and functions to strengthen compliance and efficiency. * Promote a culture of continuous improvement byidentifyingopportunities for simplification, process excellence, and digital enablement within the Quality Management System (QMS). * Ensure the teammaintainsa state ofinspectionreadiness and supports successful engagement with regulatory agencies, notified bodies, and internal audits. * MonitorQuality performance using metrics and data analytics toidentifyrisks, drive root cause analysis, and implement sustainable improvements. * Coach and mentor emerging Quality team members to build organizational capability and ensure robust succession planning. * Communicate Quality and Compliance strategy, progress, and risk mitigation plans to senior leadership and cross-functional stakeholders. * Ability to identify and drive process improvements; own process investigations, nonconformance records or corrective actions in response to audit findings. * Perform other work-related duties as assigned. Required: * Bachelor's degree in Life Sciences, Engineering, or a related technical discipline required. * 7+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries, including at least 3 years in people leadership. * Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR. * Proven ability to lead and develop high-performing teams and build future technical and people leaders * Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations. • Excellent collaboration, influence, and communication skills across functional and organizational boundaries., • Strong analytical and problem-solving skills, with experience using data to drive decision-making and improvement., • Experience leading in a matrixed, global organization and managing competing priorities effectively., • Commitment to scientific integrity, compliance excellence, and continuous improvement. Preferred: * Advanced degree (MS, PhD, MBA, or equivalent) in a relevant discipline. * Experience implementing or optimizing global Quality Management Systems (QMS) and digital tools. * Lean Six Sigma, PMP, or similar certification demonstrating process improvement expertise. * Experience supporting or leading Health Authority or Notified Body inspections. Internal: Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, GSO, Quality & Compliance teams globally and regionally. External: Regulatory agencies, Notified Bodies, Contract manufacturers, Suppliers, and service providers. Typical office or laboratory environment. May involve virtual collaboration across multiple global sites. No strenuous physical activity required. May include occasional travel for site visits, leadership meetings, or regulatory support. At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they're essential to how we thrive as a team and achieve meaningful impact: * Thrive Together - Collaborate intentionally, grow as a team * Make It Happen - Focus on priorities, embrace continuous improvement * Commit to Service - Cultivate a service mindset * Embrace Inclusion - Be open and authentic, welcome diverse perspectives Salary range for this position takes into account a wide range of factors including: education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. Salary range for this position is $135,000 to $175,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at ___. #LI-SP1

(Senior) Director, CMC QA – Permanent – New York Proclinical is seeking a (Senior) Director, CMC Quality Assurance for an emerging biotech company based in New York. Primary Responsibilities: In this role, you will be responsible for the hands-on oversight of all Quality Assurance (QA) Good Manufacturing Practices (GMP) activities pertaining to the manufacture of drug product, analytical, packaging, labeling, distribution, and release of Clinical Supplies. You will own and lead the CMC Quality function across internal operations and external partners (CMOs/CROs/contract laboratories), including batch disposition, quality systems, change management, deviations, investigations, complaints, audits, and product release activities. The position is based onsite in New York. Skills & Requirements: • B.S. or B.A. or higher degree (preferably in Life Science) with 10+ years of hands-on experience with increasing responsibility as a Quality Assurance Professional., • Experience in small molecule development, batch release, and SOP drafting., • Hands on experience implementing quality management systems in a GxP environment, and direct experience with FDA and other health authority inspections., • Strong understanding and extensive knowledge of industry practices and global regulatory requirements (FDA, EMA, ICH) for clinical-stage products., • Proven ability to build or scale quality systems in a dynamic environment., • Prior experience managing CDMOs and external quality oversight strongly preferred., • Experience in supporting IND/CTA/IMPD submissions and clinical supply release preferred. The (Senior) Director, CMC QA will: • Author, review and approve Standard Operating Procedures (SOPs), protocols, reports, specifications and other quality records for accuracy and compliance with all applicable regulations, guidance, and international standards., • Review and provide quality input for CMC sections of product registration applications, and Investigational Medicinal Product Dossier (IMPD) submissions for drug substance, drug products analytical methods and stability studies., • Develop and execute the CMC QA strategy aligned with company goals and regulatory expectations., • Build, refine, and scale quality systems appropriate for a fast-growing biotech (e.g., change control, deviations, CAPA, document control, supplier management)., • Serve as the primary QA point of contact for CMC, manufacturing, analytical development, supply chain, and regulatory teams., • Build and oversee cGMP Quality Management Systems, Batch Review and Release, Quality Control testing activities and disposition of packaging products to ensure compliance with internal procedures and global regulatory requirements (e.g., FDA, EMA, ICH).Manage quality audits at CMOs, CROs, contract labs including the implementation and monitoring of audit related corrective and preventative actions (CAPAs)., • Lead and facilitate thorough cGMP investigations for process deviations, out of specification test results, Out of Tolerance, and Out of Specifications events and identify root cause and CAPAs. Provide Quality Assurance input for failure analysis, problem solving, and risk assessment and mitigation activities related to the qualification and validation of the cGMP facility and equipment. If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or . Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.

The Senior Account Executive is a key client partner responsible for managing day-to-day relationships and leading the execution of integrated pharmaceutical and healthcare marketing initiatives in a regulated environment. This role serves as the central liaison between clients and internal teams, ensuring projects are delivered on time, within budget, and aligned with client business objectives. Working closely with strategy, creative, media, medical, and project management teams, the Senior Account Executive helps drive the successful execution of campaigns while maintaining compliance with Medical, Legal, and Regulatory (MLR) review processes, FDA guidelines, and healthcare marketing best practices. The role also supports account growth, contributes to strategic discussions, and mentors junior team members to ensure strong collaboration and high-quality deliverables. Candidates with experience at the Senior Account Executive or Account Supervisor level are encouraged to apply; title and compensation will be commensurate with experience. This position is based in New York City and follows a hybrid work model, requiring three days in the office (Tuesday–Thursday). Key Responsibilities Client Partnership & Account Leadership • Serve as a primary point of contact for assigned healthcare and pharmaceutical clients, building trusted relationships and ensuring clear communication across projects and initiatives., • Manage day-to-day account activities, ensuring work is aligned with client objectives, timelines, and budgets., • Lead the development of project briefs and ensure internal teams are aligned on deliverables, timelines, and expectations. Campaign Execution & Cross-Functional Collaboration • Partner with strategy, creative, medical, digital, media, and project management teams to deliver integrated marketing campaigns across channels., • Ensure work is on strategy, compliant with healthcare regulations, and delivered with high quality and accuracy., • Support the development of client presentations, status updates, and strategic recommendations., • Mentor and support junior account team members, helping maintain strong team collaboration and performance. Financial Management & Account Growth • Support account leadership in managing project budgets, scopes of work, and financial tracking., • Monitor timelines and budgets to ensure projects remain within scope and identify potential risks early., • Contribute to identifying opportunities to expand client partnerships and grow the agency’s scope of work., • Participate in strategic discussions and long-term planning for key accounts as appropriate. Qualifications • 3–6 years of experience in account management within an advertising, marketing, or healthcare communications agency., • Experience supporting pharmaceutical, biotech, or healthcare brands within a regulated marketing environment., • Familiarity with Medical, Legal, and Regulatory (MLR) review processes and development of compliant marketing materials., • Demonstrated ability to manage multiple projects and timelines in a fast-paced agency environment., • Experience collaborating with cross-functional teams including creative, strategy, media, medical, and analytics., • Strong communication and presentation skills with the ability to interact confidently with clients and internal teams., • Understanding of integrated marketing campaigns across multiple channels., • Bachelor’s degree in Marketing, Advertising, Communications, Business, or a related field., • Title and compensation will be commensurate with experience. EQUAL OPPORTUNITY EMPLOYER Moon Rabbit embraces and celebrates diversity, inclusivity, and equal opportunity. We are committed to building a team that reflects a wide range of backgrounds, perspectives, and experiences. As a global agency serving global clients, we believe that a more inclusive workplace enables us to produce stronger, more impactful work together. Moon Rabbit is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, gender identity or expression, sexual orientation, national origin, age, disability, veteran status, or any other protected characteristic under applicable law.

Medical Device Leader! Principal Quality Engineer Opportunity! This Jobot Consulting Job is hosted by: David DeCristofaro Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume. Salary: $65 - $85 per hour A bit about us: We are a leading medical device company that operates privately and is committed to enhancing the care and quality of life of patients with kidney disease. Our goal is to create cutting-edge solutions that enable patients and their healthcare providers to manage kidney disease with ease. Why join us? • Company Equity!, • Excellent medical, dental, & vision package!, • 401(k) with a match!, • Generous PTO!, • Opportunity to make a difference in people's lives! Job Details We are seeking a dynamic and experienced Principal Quality Engineer to join our team. This role will be responsible for leading the quality engineering initiatives ensuring ongoing safety, efficacy, and compliance of medical devices as they enter the market. The ideal candidate will have a strong background in quality engineering within the Medical Device industry, with a focus on FDA regulations, ISO 13485, CAPA, and other regulatory and compliance requirements. Responsibilities: 1. Lead the development and implementation of quality systems in compliance with FDA and ISO 13485 regulations., 2. Analyze and manage Corrective and Preventive Actions (CAPA) to ensure effective resolution of quality issues., 3. Utilize problem-solving methodologies such as Fishbone or DMAIC to identify root causes and implement corrective actions., 4. Maintain the FDA Quality Management System Reporting (QMSR) and ensure that all quality metrics are met or exceeded., 5. Provide consultation to various departments on quality systems, regulatory compliance, and risk management., 6. Conduct internal and external audits to ensure compliance with regulatory standards., 7. Lead and oversee post-market surveillance programs., 8. Collaborate with cross-functional teams to drive continuous improvement initiatives., 9. Lead the review and approval of design and process changes, ensuring compliance with quality standards and regulatory requirements. Qualifications: 1. Bachelor's degree in Engineering, Quality Assurance, or a related field is required., 2. Minimum of 12 years of experience in a quality engineering role with strong medical device industry experience., 3. Extensive knowledge of FDA regulations, ISO 13485, Fishbone, DMAIC, 8D, and/or FDA QMSR., 4. Expertise in post-market quality system activities including complaint handling, vigilance/adverse event reporting, HHE, and post-market surveillance., 5. Conduct and lead complex investigations and implement CAPA., 6. Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) is preferred. Interested in hearing more? Easy Apply now by clicking the "Apply" button. Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: jobot.com/privacy-policy

Physician Assistant – Clinical Research (Sub-Investigator) Location: Brooklyn, NY About Brooklyn Clinical Research: Brooklyn Clinical Research was founded to increase access to clinical trials for underrepresented populations. Clinical-trial enrollment should accurately represent the broader population. In meeting this objective, we help improve therapeutic efficacy and safety for all individuals. Position Overview: We are seeking a clinically adept, highly motivated Physician Assistant to join our growing research team as a Sub-Investigator. This is a hands-on clinical research role, working alongside our full-time Principal Investigator (MD) to conduct industry-sponsored clinical trials. The ideal candidate will thrive in a fast-paced, dynamic environment where flexibility, strong clinical decision-making, and attention to detail are essential. You will receive full training in clinical research and GCP, and you will play a key role in the daily conduct of clinical trials — performing protocol-specific assessments, managing study visits, and ensuring participant safety and regulatory compliance. Key Responsibilities: • Serve as a Sub-Investigator on assigned clinical trials under supervision of the Principal Investigator., • Perform protocol-required medical evaluations, including detailed histories, physical exams, safety assessments, and medical oversight of study participants., • Administer investigational products (e.g., vaccines, injectables) according to protocol., • Perform and oversee clinical procedures including phlebotomy, vital signs, ECGs, and other protocol-specified tests., • Assess and document adverse events and serious adverse events according to FDA and Sponsor guidelines., • Maintain thorough, timely, and accurate source documentation and electronic data entry (EDC, eSource, CTMS)., • Collaborate closely with clinical coordinators, regulatory staff, sponsors, and CROs., • Participate in monitoring visits, audits, and inspections., • Maintain comprehensive knowledge of study protocols, informed consent documents, and regulatory requirements., • Participate actively in team meetings, contributing to ongoing process improvement as our site grows., • Act as a supplementary Clinical Research Coordinator on an as-needed basis. Qualifications: • Graduate of an accredited Physician Assistant program (required)., • Active Physician Assistant license in New York State (required)., • Prior clinical research experience is a strong plus but not required., • Extensive background in direct patient care., • Current BLS/CPR certification. Key Attributes for Success: • Excited to work in a fast-paced clinical environment where protocols and patient needs can vary daily., • Strong clinical acumen and independent judgment., • Detail-oriented with excellent documentation skills., • Highly organized with the ability to manage multiple protocols simultaneously., • Excellent communication and teamwork skills., • Commitment to patient safety, protocol adherence, and research integrity., • Spanish fluency or medical Spanish is a plus but not required. Position Details: • Full-time, salaried position, Monday–Friday. Occasional weekend work may be required during high-volume vaccine periods., • Anticipated Start Date: Late July or Early August 2025, • Salary Range: $140,000 to $170,000 depending on experience. Why Join Us: This is an excellent opportunity for a PA who is interested in advancing their career into clinical research while maintaining direct patient interaction. You will be a key member of a high-performing, mission-driven team with meaningful opportunities for professional growth as our research site expands. Notice to Recruiters and Agencies We do not accept unsolicited resumes from headhunters, recruitment agencies, or fee-based recruitment services. Please do not forward resumes to our employees or any company location/contact. Brooklyn Clinical Research is not responsible for any fees related to unsolicited resumes. We will consider any CV or resume received without a prior, signed agreement to be the property of Brooklyn Clinical Research, and we will process it accordingly without fee or obligation.

Clinical Research Coordinator Location: Brooklyn, NY About Brooklyn Clinical Research: Brooklyn Clinical Research was founded to increase access to clinical trials for underrepresented populations. Clinical-trial enrollment should accurately represent the broader population. In meeting this objective, we help improve therapeutic efficacy and safety for all individuals. Position Overview: The Clinical Research Coordinator (“CRC”) monitors data management and regulatory aspects of clinical-trial operations and will ensure that research is conducted in accordance with the sponsor’s protocol, FDA Regulations, and ICH/GCP guidelines. The CRC will also ensure that the data provided to the sponsor are of the highest quality and that study enrollment meets or exceeds the sponsor’s expectations. As such, the CRC should be a detailed-oriented, self-motivated professional with a track record of successfully adhering to clinical-trial protocols and exceeding sponsor expectations. Our primary therapeutic areas are pain, cardiometabolic health, and vaccines. Estimated Start Date: March or April, 2026 DUTIES & RESPONSIBILITIES • Completing all relevant training prior to study start and all additional protocol amendment trainings., • Adherence to ALCOA-C Standards with all clinical trial documentation., • Working effectively with EDC, CTMS, eSource, eRegulatory, and our internal database., • Working effectively with sponsor specified IVRS and EDC systems., • Conducting and overseeing study participant visits, and all other relevant protocol-required procedures -- including blood draws -- while documenting relevant data in a timely, accurate manner., • Completing and overseeing data entry and query resolution in a timely manner as per company guidelines and sponsor expectations., • Demonstrated understanding and implementation of protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory for assigned protocols., • Liaising with the administrative staff, clinical investigators, research participants, and Sponsor/CRO representatives for assigned protocols., • Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, organizational SOPs, and assigned study protocol(s)., • Maintaining a working knowledge of the recruitment and retention processes for the assigned protocol(s)., • Preparing for Sponsor and CRO visits for the respective protocol(s)., • Maintaining a comprehensive knowledge of the most recent versions of the Study Protocols, Informed Consents, Study Manuals, and all the other relevant study-related documents that are utilized for the assigned protocols., • Managing study participants’ scheduling, visit tracking, stipends, and transportation., • Maintaining a comprehensive knowledge of all essential clinical trial documents and maintenance of the Investigator Site Binders for their assigned protocol(s)., • Work with the Principal Investigator(s) on the reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per Sponsor, IRB, and ICH-GCP Guidelines., • Work supplementally with our recruitment team to pre-screen and schedule study participants. KNOWLEDGE & EXPERIENCE Education: • Bachelor's degree in health or science-related major preferred but not mandatory, • ICH-GCP Certification and IATA Certification, • Phlebotomy Certification Experience: • 2-3 years’ experience in industry-sponsored clinical research, preferably as a CRC., • Wide therapeutic range of clinical-trial experience preferred., • Regulatory research experience is a plus. Credentials: • ACRP or equivalent certification is a plus Knowledge and Skills: • Goals-driven while continuously maintaining quality., • Must be a detail-oriented and proactive self-starter., • Must have strong written and verbal communication skills., • Must have excellent customer service skills., • Bilingual in Spanish is a plus. Salary Range: $70,000 to $80,000 depending on experience and qualifications.

Senior Clinical Trial Manager- (Sponsor-Dedicated, Remote - US) Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities Location: Remote - United States (East or Central Time preferred) Where strategy meets operational excellence. We're seeking an experienced Senior Level Clinical Trial Manager join our sponsor-dedicated team in the role of Site Monitoring Lead (SML) to supporting global clinical research programs. In this fully remote role, you'll provide leadership and expertise in site monitoring strategy, execution, and oversight-ensuring clinical trial quality, subject safety, and data integrity across multiple regions. The SML serves as a core member of the Trial Team, leading the implementation of the site monitoring and oversight approach as part of overall trial quality management. This role is critical to delivering clinical programs on time and to the highest compliance standards, in alignment with ICH-GCP, regulatory expectations, and sponsor requirements. * Lead and oversee site monitoring activities across assigned global clinical trials, ensuring effective implementation of trial-specific monitoring strategies. * Consult and provide expertise to Trial Teams on monitoring methodologies, risk-based approaches, and oversight activities throughout all trial phases. * Ensure trial participant safety, data integrity, and regulatory compliance in accordance with study protocols, ICH-GCP, and applicable global regulations. * Manage trial-level planning, implementation, issue management, and risk mitigation related to site monitoring activities. * Support inspection readiness at all times by maintaining robust oversight, documentation, and communication processes. * Represent the function in meetings with investigational sites, vendors, and internal/external stakeholders, including regulatory agencies or inspectors when needed. * Contribute to innovation and process improvement, including the design and implementation of new monitoring methods and digital solutions related to trial delivery. * Collaborate cross-functionally with Clinical Operations, Quality, and other global teams to ensure seamless execution and alignment on monitoring objectives. * Bachelor's degree in Life Sciences or a related discipline; advanced degree preferred. * Demonstrated experience as a Clinical Trial Manager (or equivalent trial-level role) with accountability for end-to-end study execution, including planning, conduct, oversight, and closeout of clinical trials. This role requires ownership of the trial at the program level and is not a site-monitoring or CRA position. * Proven leadership of early-phase (Phase I and IIa) clinical trials, including operational strategy, risk management, and execution for complex, early-stage patient populations (not limited to first-in-human studies but must include). * Oversight-not execution-of site monitoring activities, including management and performance oversight of CRAs and/or CRO partners, issue escalation, and proactive risk mitigation. * Deep expertise in clinical operations with trial-level decision-making authority, including protocol implementation, deviation management, inspection readiness, and resolution of operational challenges. * Strong working knowledge of ICH-GCP, Good Documentation Practice, and global regulatory requirements, with the ability to apply these principles at the study oversight level across FDA, EMA, and PMDA-regulated trials. * Experience leading global, multi-regional trials within a matrixed, cross-functional environment, partnering closely with Clinical Operations, Data Management, Safety, Regulatory, Biometrics, and external vendors. * Demonstrated ability to manage CROs and functional vendors, including monitoring, central labs, imaging, and other service providers, ensuring delivery against timelines, quality, and study objectives. * Advanced project and trial management capabilities, including ownership of study timelines, milestone delivery, operational risk identification, and resolution across competing priorities. * Excellent communication and stakeholder management skills, with the ability to lead and influence CRAs, vendors, and cross-functional teams in a global, matrixed structure. * Demonstrated Agility, Accountability, and Intrapreneurship (AAI), with a results-oriented mindset, sound judgment, and the ability to make informed decisions in a fast-moving early-phase environment. * * Opportunity to shape and optimize site monitoring strategies across diverse, high-impact clinical programs. * Work within a collaborative, science-driven culture that values innovation, agility, and excellence in delivery. * Engage directly with global teams, vendors, and regulatory stakeholders to drive success from early development through marketing authorization. * A dynamic environment that rewards leadership, critical thinking, and operational insight. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $95,000.00 - $175,700.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Clinical Project Manager II - Biomarker Study Management (Sponsor-Dedicated | Remote) Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities We're hiring a Clinical Project Manager II with a strong background in biomarker study operations to join our sponsor-dedicated team. This fully remote role gives you the opportunity to drive the success of global clinical trials by leading biomarker and bioanalytical strategy from start to finish. You'll be a key player in bringing together cross-functional teams, vendors, and internal stakeholders to ensure biological samples are collected, managed, and analyzed to the highest standards. What You'll Do: Lead Biomarker Study Operations * Oversee biomarker and bioanalytical activities across Sponsor and Collaborative programs * Serve as the operational point of contact for all biomarker-related processes * Work closely with clinical study teams (Phases 1-4) to integrate biomarker strategies into broader clinical development plans * Plan and manage the collection, tracking, and analysis of biological specimens * Advise study teams on best practices for sample management and logistics Drive Clinical Project Delivery * Lead cross-functional teams through the full clinical trial lifecycle, from start-up to closeout * Ensure studies stay on track with respect to timelines, budget, scope, and quality * Act as the main liaison between the sponsor and study partners * Monitor and manage project financials, ensuring fiscal responsibility * Proactively identify and resolve operational issues and risks Ensure Operational Excellence * Maintain high-quality documentation, including Trial Master File (TMF) accuracy and completeness * Keep study systems and databases current and audit-ready * Prepare project reports and updates for sponsors and internal stakeholders * Plan and facilitate internal and external meetings * Support inspection readiness and regulatory compliance throughout the project * Significant experience managing biomarker studies and external vendors required! * Strong understanding of biomarker and bioanalytical strategies in a clinical trial setting * Proven ability to coordinate complex sample collection and analysis workflows * Expertise in supporting study teams with sample logistics and operational planning * Bachelor's degree in Life Sciences, Medicine, Pharmacy, Nursing, or equivalent combination of education and experience * Experience in a clinical research organization (CRO) or sponsor environment preferred * Familiarity with GCP, ICH guidelines, and global regulatory standards * Strong project management, organizational, and communication skills * Comfortable working independently and embracing new technologies * Willingness to travel up to 25% as needed * Meaningful Work: Your contributions will directly support critical biomarker research that shapes the future of clinical development and precision medicine. * Global Impact: You'll be working on high-profile studies that span multiple regions, making a real difference in patients' lives around the world. * Dedicated Team: Join a collaborative, sponsor-dedicated environment where your expertise is trusted, and your voice matters. * Flexibility: Enjoy the freedom of a fully remote role with the support of a structured, responsive team. * Professional Growth: Be part of a company that invests in your career through continued learning, mentorship, and leadership opportunities. * Stability and Vision: Work with a leading global organization known for operational excellence and long-term partnerships in clinical research. If you're passionate about clinical research and want to make a direct impact on advancing biomarker science, we'd love to hear from you. Apply now and be part of a team shaping the future of clinical development. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Experienced Clinical Research Associate - Full-Service - Oncology Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities • Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes., • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues., • Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements., • May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned., • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations., • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution., • For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets., • May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements, • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements., • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. Qualifications: • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience, • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements, • Must demonstrate good computer skills and be able to embrace new technologies, • Excellent communication, presentation and interpersonal skills, • Ability to manage required travel of up to 75% on a regular basis, • US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Site Care Partner (Sr CRA II) - Sponsor Dedicated | Oncology | 5 years of monitoring experience required (Home-Based - United States) Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities • Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes., • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues., • May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned., • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations., • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and action items to resolution., • Understands project scope, budgets, and timelines for own and others' activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets., • May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements., • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in and may lead global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements., • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions., • May provide direct supervision, training and/or mentorship to more junior level CRAs. Performs training and sign off visits for junior CRA staff, as assigned. May be mentored and assigned lead tasks under supervision of an experienced Clinical Operations Lead (COL) or operational line manager. This could include participation in business development proposals and/or defense meetings. Qualifications: • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience, • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements, • Must demonstrate good computer skills and be able to embrace new technologies, • Excellent communication, presentation and interpersonal skills. Moderate level of critical thinking skills expected., • Ability to manage required travel of up to 75% on a regular basis At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $80,600.00 - $145,000.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Support regulatory submission/publishing activities for eCTD global submission dossiers according to Agency and ICH Guidance requirements for major filings, (IND, NDA, sNDA, Amendments, DMFs, etc.) and regulatory maintenance activities. Support global submission timelines and coordination of publishing activities of work-related experience required for this position. Solid knowledge of submission requirements for regional markets may be required to ensure the overall submission and quality of the dossier meets regulatory compliance. Essential Functions Submission Management & Publishing Tasks: Manage assigned regulatory activity projects and closely collaborates with Senior Managers from GSM, Regulatory Affairs and other functional areas for the planning and publishing of regulatory submissions, monitoring submission forecast and ensuring timely high quality of regulatory submissions are submitted to health authority within required submission timelines. Publishing regulatory submissions (bookmarks, hypertext links, QC) scheduled to be submitted to regulatory agencies (e.g., FDA, EMA and Health Canada). Publishing Tasks: Assists with hands-on daily submission compilation and publishing activities associated with preparation of various dossier types Submission Specialist Tasks: • Responsible for publishing, review, submission compilation and archive for routine regulatory activities (e.g. Amendments) and complex eCTD submissions (e.g. IND, NDA)., • Uses internal and industry best practices in order to ensure quality submission deliverables., • Provide operational oversight to ensure timely, high quality regulatory submissions, • Participates in the development of optimal business processes (internal guides, SOPs, etc.) and practices within the department to ensure high levels of customer support and to achieve high quality submissions. Identifies and advises management with regards to opportunities for efficiencies, business process improvements, and cost reductions., • Position accountability/scope includes supervision of certain projects and assistance with priority setting required. Receives project assignments from manager, but has the responsibility for independently managing and executing own projects. Reviews project progress with manager on a regular basis with direction provided on follow-up., • Identifies opportunities and advises management for process improvements or cost savings. May participate on internal project teams in order to guide and update business processes., • Supports various document management assignments, including file transfer, archiving, tracking, and archival of Regulatory submission documentation (including SPL, FDA correspondence and submission)., • Demonstrates team leadership skills and ability to positively influence and work with others. Builds and maintains positive relationships internally and externally., • Participates in other key projects and activities as assigned by management to support the Regulatory Operations function including submission authoring and Regulatory Systems implementation projects. Publishing Tasks: Assist with hands-on daily submission compilation and publishing activities associated with preparation of various regulatory submission types. Applies good judgment and demonstrates initiative to resolve issues. • Expert understanding of Project Management tools and techniques., • Ensures publishing activities are processed in accordance with established SOPs., • Collaborate timeline with the regulatory affairs representatives, maintains the submission timelines, obtain status updates from the Publishing Manager and subteam members, RA Leads and reports submission status and activities to various stakeholders., • Update the regulatory submission calendar, and reports on key submission milestones to stakeholders, as applicable. Business Process Development & Problem Solving: • Participate and contribute to new and updated process and procedures. Review regulatory documents to ensure compliance with submission guidelines to drive efficient future state process including gaining buy in for key stakeholder and drive to standardization of processes., • Identifies risks and opportunities and addresses as needed with a focus on regulatory compliance requirements by supporting best practices, Working Procedures and SOPs., • Support process updates due to changing regulations that impact submission strategies and technologies, SEND, CDISC, Validator Software, etc. This includes not limited to identifying the validation checks needed to ensure compliance with eCTD Specifications for world-wide regulatory agencies., • May participate on internal project teams in order to guide and update business processes, as applicable. Regulatory Information Applications & Technology: • Support technology activities to ensure that regulatory information applications and systems are implemented, validated, and maintained in accordance with regulatory requirements compliance including but not limited to performing UAT scripts)., • Support Global System development and process development on a basic level, and process redesign., • Technical knowledge of the US and global regulatory requirements for electronic submissions Regulatory Training: Support and coordinate training to global submission management, regulatory publishing and other functional areas. Regulatory Submission Intelligence: Perform and collect regulatory information applicable to global electronic submissions guidance, publishing tasks, data standards, and technology and marketing trends in regulatory space. Ability to gather data, analyze research material information and communicate to management potential impact on regulatory operations strategies, and/or identify hot topic issues. Responsible for staying abreast of US, Harmonized (ICH) eCTD and Global guidances, and provide updates as required Requirements • Bachelor's Degree required, preferably in science or health related discipline, • Minimum 3-5 years pharma experience, including at least 1-2 years submission experience, • Experience regulatory professional that understands regulatory submission/ePublishing requirements for filing original applications, amendments, complex supplements/variations and line extensions, as well as routine submissions., • Excellent communication skills required to interact effectively with regulatory affairs members and regulatory colleagues in gathering the necessary information required for submissions, and to proactively address sensitive issues with diplomacy and tact., • Applies good judgment and demonstrates initiative to resolve issues., • Advance understanding of Submission Project Management tools and techniques., • Ensures submissions are processed in accordance with established SOPs., • Excellent analytical and problem solving skills: facilitating team(s) to identify issues and propose solutions with respect to regulatory eCTD submission issue, • Strong Communication Skills: Excellent verbal and written communication skills with demonstrated ability to present and articulate requirements with regulatory affairs members and regulatory colleagues proactively. Ability to foster and maintain relationships with strategic global regulatory organization and other functional partners to ensure understanding of current processes., • Project Management Skills: Strong project management skills with attention to detail, ability to work in a fast-paced environment while successfully prioritizing and working on multiple tasks while utilizing organizational skills., • Knowledge of Drug Development: Experience in regulatory operations or regulatory affairs with advanced knowledge of pharmaceutical development (e.g. CMC, Nonclinical, Clinical), • Technology & Software Skills: Advanced working knowledge of global eCTD publishing and Electronic Document Management technology, ISI Toolbox, Regulatory Tracking Systems (RTS) and related technology applications. Advanced user skill in MS Word, MS Sharepoint, Adobe Acrobat Professional, eCTD content templates and experience., • Teamwork Skills: Experience in working on teams and to establish effective relationships with team members., • Critical Thinking and Problem Solving Skills: Ability to track regulatory eCTD submission changes (e.g. regional DTD upgrade or system upgrades) and interpret potential implications for regulatory activities, training and/or timelines. Ability to identify the root cause of problems as well as the implications associated with potential solutions and communicate to management. Eisai Salary Transparency Language: The annual base salary range for the Senior Associate, Global Submission Management is from :$82,500-$108,300 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Job Summary: Reporting to the Director of Global Labeling, the Manager, Global Labeling is responsible for supporting Global Labeling Leads in daily operational labeling activities (US and global); managing and maintaining US SPL, drug listings, and establishment registrations; triaging, reviewing, and tracking Country Product Information (CPI); and performing operational activities that support Global Labeling deliverables and responsibilities. The primary responsibilities will be structured product labeling and maintaining drug listings. Essential Functions • Collaborate with key stakeholders to facilitate and lead cross-functional teams in the development, review, approval, and maintenance of the establishment registration and drug listing (bulk and finished) in the US., • Perform bi-annual review and submission of FDA-required drug listings and establishment registrations., • Act as a Subject Matter Expert (SME) on US Structured Product Labeling (SPL): Provide guidance and support for the U.S. drug listings and Structured Product Labeling (SPL), partner with an external service provider to deliver on SPL commitments., • Collaborate with global stakeholders and stay abreast of structured product labeling developments, requirements, and formats in rest of world, • Be familiar with National Drug Code (NDC), Dun and Bradstreet Number (DUNS), FDA Establishment Identification (FEI), and Global Trade Identification Number (GTIN) requirements, • Review and track requests for updates to Country Product Information (CPI) and CPI components. This includes QC, proofing, copy editing and formatting of documents, and coordinate review by Global Labeling Lead., • Attend necessary labeling team meetings to discuss decisions regarding any label and CPI updates, discuss any findings of meaningful differences among Source Reference Labels (SRLs) and CPIs., • Represent the Global Regulatory Services and Operations (GRSO), Global Labeling Group on project teams., • Support the use and development of current and new tools, technologies, and processes to support global label development, submission, approval, and dispatch of Source Reference Labels in and to respective countries in addition to global label support., • Track periodic CCDS reviews to ensure compliance with internal procedures and timelines., • Maintain labeling history documents and assist in responding to labeling-related queries from various functional areas., • Ensure all actions taken within role follow applicable SOPs and associated documents so that high quality delivery of outputs and compliance is maintained., • Ensure appropriate tracking of labeling projects via defined procedures and optimal use of systems., • Participate in and contribute to the continuous improvement efforts related to business practices and tools utilized within role., • Contribute and support the development and maintenance of job aids and guidance documents., • Support compliance activities including audits, inspections, and labeling-related escalations and non-conformances Requirements • BS degree (or higher) in life science, • A minimum of 4 years of experience in the pharmaceutical industry is required, • A minimum of 2 years of experience in product labeling/labeling regulations is required, • Can demonstrate strong project management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (both written and oral), attention to detail and ability to work under tight timelines, and across teams and regions, • Possess experience in both local and global regulatory labeling environments and work on multiple projects, • Must be a team-oriented individual with personal commitment to human relations, integrity, giving and receiving feedback, adaptability, and a diverse working environment, • Able to work under pressure and enforce company-wide standards, • Must possess a strong working knowledge of Microsoft Office applications, document management systems, labeling text verification systems as well as related labeling software and trackers Eisai Salary Transparency Language: The annual base salary range for the Manager, Global Labeling - Remote is from :$100,000-$131,300 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Director, Global Labeling is responsible for the leadership and oversight of the Labeling function within Global Regulatory Services and Operations (GRSO). This position will manage labeling operations and actively contribute to the development and implementation of regulatory labeling strategy and documentation for marketed products and products in development. This job serves as an expert on regulations governing labeling of pharmaceutical products globally, and serves as the global regulatory labeling representative on relevant project teams to provide strategic input into the development and approval of Target Product Profile (TPP) for development products and all Eisai product Company Core Data Sheets (CCDSs), US Package Inserts (PIs), European Union (EU) Summary of Product Characteristics (SmPCs) and Emerging Market labels. This position manages a team of professionals located in the US and UK, and is responsible for employee-related activities, including resource management, performance management, coaching and mentoring on both operational and strategic aspects of labeling, and fostering a culture of proactive people development. Essential Functions • Lead cross-functional teams in the timely development of content for a new or revised CCDS, USPI, EU SmPC and Emerging Markets labels for assigned products, following internal procedures for review, approval and implementation of labels. Acts as liaison between co-promote partners and Eisai stakeholders in the labeling process., • Establish and maintain processes and standards for global labeling. Supervise direct reports to effectively operationalize labeling activities across all products. Develop and mentor direct reports on both operational and strategic aspects of labeling., • Responsible maintaining the Drug and Establishment Listings for all of Eisai's products., • Maintain centralized labeling repository within Eisai's electronic document management system for all global labels at various stages of development, review and approval. Manage labeling development, review and approval workflows within the electronic documents management system and track the timely and consistent implementation of safety changes in local labels., • Provide labeling support for Eisai US and EU Packaging Engineering functions for artwork control and approval., • Ensure consistency of labeling across product lines and compliance with Eisai policies and procedures and applicable regulatory authority directives and regulations. Analyze competitor labeling and ensure Eisai products have most competitive labeling., • Manage a team of professionals in the US and UK. Responsible for all employee-related activities throughout the year, including performance management and development., • Maintain expertise regarding key labeling requirements worldwide and stay current with labeling guidelines and regulations by FDA, EMA and other applicable regulatory authorities. Represent the Global Labeling group on Regulatory Sub-teams and other project teams to communicate key strategies. Requirements • Bachelors degree in life sciences required; higher degree preferred, • Minimum of 10 years of experience in Regulatory, R&D or related area, • Pharmaceutical experience required, • Solid working knowledge of drug development process, • Solid working knowledge and experience of global regulatory labeling environments and requirements, • Solid knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines., • Strong project management, people management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (written and oral), • Ability to work under tight timelines, • Attention to detail Eisai Salary Transparency Language: The annual base salary range for the Director, Global Labeling is from :$180,700-$237,200 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

Principal/Sr Medical Editor - Regulatory Documents - Copy Editing + QC - NA/Canada Remote Based Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities *Maintains strong familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance. *Represents the editorial group in medical writing, on study teams, and in cross-departmental project teams as needed. *Monitors timelines and budgets for assigned projects and updates the lead medical writer, project manager, and/or direct supervisor (as appropriate) if deliverables are at risk. *Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor. Advises medical writers, medical editors, and study teams on quality review, compilation, and editorial standards. Provides training to members of the global medical writing team in aspects relative to their roles. *Serves as project lead for deliverables of assigned complex and/or large medical writing projects, including, but not limited to, scheduling and leading internal project-specific team meetings, organizing project-specific requirements, and ensuring all information is distributed to the editorial team and implemented within the deliverable. *Serves as a member of the medical writing team for projects with medical writing deliverables. Provides feedback to the lead medical writer on progress of editorial process. *Copyedits assigned documents, applying correct grammar, punctuation, spelling, and style following AMA Manual of Style or various custom style guidelines as well as established medical writing internal checklists and best practices. *Performs quality review of assigned documents to ensure accuracy. *Contributes to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work. *Manages assigned projects according to medical writing standard operating procedures and client standards, on time and on budget. *May compile medical writing deliverables. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $62,000.00 - $108,600.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Medical Science Liaison (MSL or Sr. MSL) is a field-facing representative of US Medical Affairs with a primary responsibility of engaging in the exchange of scientific data and other medical and/or scientific information with KOLs/HCPs, researchers, pharmacists, and decision makers in the areas of Eisai's interest. The person in this position will demonstrate a thorough understanding of Alzheimer's disease (AD), including the needs, issues and priorities as they relate to Eisai's strategic medical plan. MSLs will be trained and certified on AD and Eisai's dementia pipeline data in order to fulfill educational gaps with KOLs/HCPs and gather medical insights to refine medical strategy and continue to close the gap on unmet educational needs for AD HCPs. MSLs also assume responsibility for special internal/external projects as they arise. The impact that a MSL will have on the organization includes the following: a) as a representative of Eisai, a MSL will communicate key information about Eisai, the company and its hhc mission; b) provide key scientific and clinical information about Eisai's products/pipeline; serve as a conduit for communication between Eisai Research and the medical community regarding ideas for future research, and c) provide corporate value through demonstrated leadership, teamwork, participation in strategic thinking, and special projects ESSENTIAL FUNCTIONS: Product/Therapeutic Area Support to Stakeholders • Act as the primary clinical/scientific resource to HCPs in the territory for information pertaining to disease state and Eisai's product(s) to ensure awareness and understanding., • Serve as a conduit for accurate and updated clinical, scientific and medical information between Key Opinion Leaders (KOLs)/investigators and the company's Medical Affairs and development groups., • Establish, foster, cultivate and maintain peer relationships with KOLs in AD and dementia in which Eisai has current and future interests., • Present clinical and scientific data on Eisai's products and relevant therapeutic areas, as requested., • Support assigned professional congresses in accordance with MSL plan. Be prepared to lead congress coverage efforts, including coordination of all MSL activities., • Identify and report key scientific, clinical and research insights from KOLs to Medical Affairs. Training/Education Resource • Maintain and demonstrate thorough and up-to-date knowledge of disease state, study methodology, clinical information, and product data, • Demonstrate full knowledge of and ability to execute on approved medical platforms/strategies and MSL initiatives, • Serve as technical/scientific subject matter resource to Eisai cross functional partners, • Teach, coach and mentor new or less experienced MSLs; assist with supervision/performance evaluation; assume responsibility for special projects. Provide valuable contributions to the organization including leadership and strategic planning., • Ability to lead and motivate team members without a direct reporting relationship Research Support • Facilitate review and follow up of submitted Investigator-Initiated Studies (IISs) and assist with Eisai sponsored trials., • The MSL may also be involved with providing recommendations for site selection and scientific expertise to Investigators involved in company sponsored studies. REQUIREMENTS: Educational Requirements: Advanced terminal D degree in medical or health sciences (e.g MD/DO, PhD, PharmD) Experience: • 2-3 years MSL experience in neurology or complex disease states; prior dementia or AD research experience strongly preferred, 3 yrs+ required for Sr MSL title., • Established relationships with KOLs in neurology, and knowledge of institutions focused on AD preferred., • 3-5 years industry/ clinical research/ related experience in a scientific or clinical setting., • Strong broad-based scientific and pharmaceutical knowledge., • Clinical trial development and drug launch experience is strongly preferred, • Knowledge of treatment guidelines, clinical research processes, FDA regulations, pharma regulations/compliant practices, and OIG guidelines are required., • Knowledge and experience within AD and ability to communicate with confidence and accuracy across multiple dementia disease states. Other Skills and Abilities: • Interested and skilled in communicating complex data sets and the ability to be seen as a scientific peer while educating top KOLs., • Committed to the concept of team and working within the framework of the Medical Affairs., • Strong overall written and verbal communication skills. Keen understanding of your audience and ability to tailor information appropriately., • Highly skilled in the art of strategic conversation along with a demonstrated ability to assess issues, as they arise and adapt appropriately., • Demonstrated ability to anticipate, organize, plan and handle multiple priorities, while adapting to the needs of the company and KOLs., • Has an ability to work independently and not require close supervision while adhering to compliance/regulatory policies., • Interest in leading and participating in projects while effectively balancing field work., • Demonstrated ability to proactively identify opportunities/challenges, willingness to communicate these challenges to leadership while working together to overcome them., • Seamlessly adapts to field situations and effectively problem solves within your territory., • Experience working in matrix environment including cross-functional commercial partners, with an understanding of the pharmaceutical corporate environment and appreciation for Commercial Operations, including Marketing and Sales strategies, • Sound computer/technology skills including applications for word processing, producing slide materials, working with spreadsheets, and video conferencing, • Possesses and maintains a valid driver's license and clean driving record., • Capable of engaging in frequent business travel (approximately 60% of time), including air travel, ability to travel overnight and occasionally on weekends., • This is a field-based position. The employee is required to set up a home-based office within their defined territory. Salary range for MSL is $144,300.00 - $189,400 USD Annual Salary range for Sr. MSL is $160,100.00 - $210,100 USD Annual #LI-MI1 As a condition of employment and an essential function of this field-based position, applicants must be able to engage in person with HCPs and other third parties at their offices, institutions and other appropriate locations on a regular basis. In order to gain in-person access, applicants selected for the position may be required to complete third parties' credentialing and/or entry requirements, which often include an attestation to and/or providing proof of having received certain vaccinations. To the extent you are unable to meet certain requirements for qualifying medical (including pregnancy-related) or religious reasons, applicants must request a reasonable accommodation by contacting the Human Resources Department.Skills:Communication & Cross-functional Influence, Critical Thinking & Agility, Healthcare Environment Dynamics, KOL/ HCP Engagement, Medical Data and Insights, Mentoring, Resource Planning & Management, Territory Management (MSL) Eisai Salary Transparency Language: The annual base salary range for the MSL/Senior Medical Science Liaison, Neurology (Alzheimer's Disease) - Field Based, Northern and Central Florida - Field Based is from :$165,300-$216,900 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Medical Science Liaison (MSL or Sr. MSL) is a field-facing representative of US Medical Affairs with a primary responsibility of engaging in the exchange of scientific data and other medical and/or scientific information with KOLs/HCPs, researchers, pharmacists, and decision makers in the areas of Eisai's interest. The person in this position will demonstrate a thorough understanding of Alzheimer's disease (AD), including the needs, issues and priorities as they relate to Eisai's strategic medical plan. MSLs will be trained and certified on AD and Eisai's dementia pipeline data in order to fulfill educational gaps with KOLs/HCPs and gather medical insights to refine medical strategy and continue to close the gap on unmet educational needs for AD HCPs. MSLs also assume responsibility for special internal/external projects as they arise. The impact that a MSL will have on the organization includes the following: a) as a representative of Eisai, a MSL will communicate key information about Eisai, the company and its hhc mission; b) provide key scientific and clinical information about Eisai's products/pipeline; serve as a conduit for communication between Eisai Research and the medical community regarding ideas for future research, and c) provide corporate value through demonstrated leadership, teamwork, participation in strategic thinking, and special projects ESSENTIAL FUNCTIONS: Product/Therapeutic Area Support to Stakeholders • Act as the primary clinical/scientific resource to HCPs in the territory for information pertaining to disease state and Eisai's product(s) to ensure awareness and understanding., • Serve as a conduit for accurate and updated clinical, scientific and medical information between Key Opinion Leaders (KOLs)/investigators and the company's Medical Affairs and development groups., • Establish, foster, cultivate and maintain peer relationships with KOLs in AD and dementia in which Eisai has current and future interests., • Present clinical and scientific data on Eisai's products and relevant therapeutic areas, as requested., • Support assigned professional congresses in accordance with MSL plan. Be prepared to lead congress coverage efforts, including coordination of all MSL activities., • Identify and report key scientific, clinical and research insights from KOLs to Medical Affairs. Training/Education Resource • Maintain and demonstrate thorough and up-to-date knowledge of disease state, study methodology, clinical information, and product data, • Demonstrate full knowledge of and ability to execute on approved medical platforms/strategies and MSL initiatives, • Serve as technical/scientific subject matter resource to Eisai cross functional partners, • Teach, coach and mentor new or less experienced MSLs; assist with supervision/performance evaluation; assume responsibility for special projects. Provide valuable contributions to the organization including leadership and strategic planning., • Ability to lead and motivate team members without a direct reporting relationship Research Support • Facilitate review and follow up of submitted Investigator-Initiated Studies (IISs) and assist with Eisai sponsored trials., • The MSL may also be involved with providing recommendations for site selection and scientific expertise to Investigators involved in company sponsored studies. REQUIREMENTS: Educational Requirements: Advanced terminal D degree in medical or health sciences (e.g MD/DO, PhD, PharmD) Experience: • 2-3 years MSL experience in neurology or complex disease states; prior dementia or AD research experience strongly preferred, 3 yrs+ required for Sr MSL title., • Established relationships with KOLs in neurology, and knowledge of institutions focused on AD preferred., • 3-5 years industry/ clinical research/ related experience in a scientific or clinical setting., • Strong broad-based scientific and pharmaceutical knowledge., • Clinical trial development and drug launch experience is strongly preferred, • Knowledge of treatment guidelines, clinical research processes, FDA regulations, pharma regulations/compliant practices, and OIG guidelines are required., • Knowledge and experience within AD and ability to communicate with confidence and accuracy across multiple dementia disease states. Other Skills and Abilities: • Interested and skilled in communicating complex data sets and the ability to be seen as a scientific peer while educating top KOLs., • Committed to the concept of team and working within the framework of the Medical Affairs., • Strong overall written and verbal communication skills. Keen understanding of your audience and ability to tailor information appropriately., • Highly skilled in the art of strategic conversation along with a demonstrated ability to assess issues, as they arise and adapt appropriately., • Demonstrated ability to anticipate, organize, plan and handle multiple priorities, while adapting to the needs of the company and KOLs., • Has an ability to work independently and not require close supervision while adhering to compliance/regulatory policies., • Interest in leading and participating in projects while effectively balancing field work., • Demonstrated ability to proactively identify opportunities/challenges, willingness to communicate these challenges to leadership while working together to overcome them., • Seamlessly adapts to field situations and effectively problem solves within your territory., • Experience working in matrix environment including cross-functional commercial partners, with an understanding of the pharmaceutical corporate environment and appreciation for Commercial Operations, including Marketing and Sales strategies, • Sound computer/technology skills including applications for word processing, producing slide materials, working with spreadsheets, and video conferencing, • Possesses and maintains a valid driver's license and clean driving record., • Capable of engaging in frequent business travel (approximately 60% of time), including air travel, ability to travel overnight and occasionally on weekends., • This is a field-based position. The employee is required to set up a home-based office within their defined territory. Salary range for MSL is $144,300.00 - $189,400 USD Annual Salary range for Sr. MSL is $160,100.00 - $210,100 USD Annual #LI-MI1 As a condition of employment and an essential function of this field-based position, applicants must be able to engage in person with HCPs and other third parties at their offices, institutions and other appropriate locations on a regular basis. In order to gain in-person access, applicants selected for the position may be required to complete third parties' credentialing and/or entry requirements, which often include an attestation to and/or providing proof of having received certain vaccinations. To the extent you are unable to meet certain requirements for qualifying medical (including pregnancy-related) or religious reasons, applicants must request a reasonable accommodation by contacting the Human Resources Department.Skills:Communication & Cross-functional Influence, Critical Thinking & Agility, Healthcare Environment Dynamics, KOL/ HCP Engagement, Medical Data and Insights, Mentoring, Resource Planning & Management, Territory Management (MSL) Eisai Salary Transparency Language: The annual base salary range for the Medical Science Liaison (MSL) / Senior Medical Science Liaison (Sr. MSL), Alzheimer's Disease (Northern CA) - Field Based is from :$160,100-$210,100 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Job Profile Summary The Associate Director, Medical Information Oncology, is responsible for leading and driving Global & US Medical Information activities for assigned therapeutic area(s) to meet the Eisai product information needs of external customers and internal business partners. This role is seen and sought after for their subject matter expertise in Oncology and assigned therapeutic area(s) and serves as medical reviewer of Eisai's advertising, promotional, and scientific exchange materials as part of Copy Review Committee and Medical Review Committee. Beyond traditional responsibilities, this position offers a unique opportunity to optimize and communicate medical information insights as part of a broad, cross-functional strategic team, ensuring these insights inform decision-making and drive innovation across the organization. The Associate Director will also leverage and implement AI-driven tools and capabilities in new and transformative ways, enhancing efficiency, personalization, and scalability of medical information services. The AD, Medical Information contributes to the development and implementation of medical plans, including the creation of standard medical responses, development of AMCP dossiers, compendia submissions, and other medical information deliverables. This role is also responsible for oversight or management of Medical Information Specialists/Managers, budget management of assigned activities, contributing to performance improvement activities, conducting quality monitoring, tracking and reporting of medical information insights and metrics, ensuring regulatory compliance, inspection readiness, and appropriate documentation and reporting of product incident reports. Responsibilities (Expanded) * Develop and manage tactical execution of the Medical Information component of Global & US Medical Affairs strategic plans for assigned therapeutic area(s). * Develop and ensure high-quality, balanced, and scientifically accurate documents in response to medical inquiries from external customers and internal stakeholders; conduct quality assurance measures and handle escalated inquiries as needed. * Lead and drive the development of Medical Information deliverables, including research and analysis of the scientific literature, standard medical responses (SMRs), verbal responses to FAQs, AMCP dossiers, compendium and pathways submissions, etc. * Serve as medical reviewer, ensuring medical accuracy and provision of feedback for Eisai's advertising, promotional, and medical materials as part of Copy Review Committee and Medical Review Committee. * Lead and provide oversight of department reporting processes, KPIs, insights analytics, digital analytics, and other trend reports that are shared with internal stakeholders; proactively identify opportunities to optimize insights for strategic decision-making. * Explore and implement AI-driven tools and technologies to enhance medical information processes, improve efficiency, and deliver innovative solutions for internal and external stakeholders. * Liaise with global and regional medical affairs colleagues as appropriate. * Provide strong scientific support for conference and booth coverage. * Implement and participate in department training, process and performance improvement activities, quality monitoring, metrics tracking, regulatory compliance, inspection readiness, and product incident response. * Serve as a business partner to internal and external collaborators as needed to support scientific exchange activities and address critical escalations as warranted. * Provide mentoring, guidance, and training to new hires/less experienced colleagues. * May provide direct supervision of Medical Information Sr Managers, Specialists, and contractors, as appropriate. * Travel required up to 30% of time. * Hybrid based in Nutley, NJ (in office Tuesday, Wednesday and Thursday) Qualifications: * Advanced degree in sciences or related field with 10+ years of experience in the pharma/biotech industry OR a combination of equivalent education and experience. * Strong scientific knowledge and expertise in Oncology, including evaluating and communicating clinical trial and disease state information to a wide range of audiences. * Demonstrated experience in conducting scientific literature review, and management of medical inquiries, including the development and review of medical information deliverables (e.g., standard medical response documents, FAQs, dossier, compendium submissions, etc.) * Practical experience and knowledge of FDA guidance on appropriate scientific exchange practices. * Previous experience of managing/leading teams directly/indirectly or coaching and mentoring new hires/less experienced colleagues. * Proficiency with Microsoft Office Suite software, SharePoint, Veeva, customer relationship management software, and other technology and telephony systems. Additional Preferred Qualifications: * Experience with AI tools, digital innovation, and data analytics to enhance medical information processes and insights. * Ability to identify and implement emerging technologies to optimize workflows and deliver innovative solutions. * Strong understanding of data visualization and insights reporting to support strategic decision-making. Skills:Communication & Cross-functional Influence, Critical Thinking & Business Agility, Healthcare Environment Dynamics, Inquiry Resolution, Literature Evaluation, Medical Information Writing Skills, Medical Review, Mentoring/ People Development, Resource Planning & Management Eisai Salary Transparency Language: The annual base salary range for the Associate Director, Medical Information, Oncology is from :$164,600-$216,100 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

Experienced Clinical Research Associate - Full-Service - Ophthalmology Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities • Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes., • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues., • Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements., • May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned., • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations., • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution., • For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets., • May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements, • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements., • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. Qualifications: • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience, • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements, • Must demonstrate good computer skills and be able to embrace new technologies, • Excellent communication, presentation and interpersonal skills, • Ability to manage required travel of up to 75% on a regular basis, • US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Job Summary: The Manager, Graphics Design is a self-directed contributor responsible for design and development of pharmaceutical product labeling artwork for primary and secondary packaging of pharmaceutical products, package inserts, and trade labeling. These activities support proposed, new, and existing commercial products. This position demonstrates high level performance and delivers high quality labeling artwork design for product packaging on schedule to meet patient, company, and regulatory needs. This position is responsible for development of, and company adherence to, cGMP compliant prescription pharmaceutical labeling artwork control and approval systems and procedures. This position requires continuous collaboration with multiple internal Eisai departments, Global Regulatory Affiliates, and Corporate Alliance Partners to assess labeling artwork needs and provide quality, compliant product labeling artwork for global product distribution. This position is responsible for security and control of Eisai Raleigh managed product labeling artwork files and electronic labeling artwork file systems. This position manages the graphic design contract service providers as needed to support high volume, critical path projects. The Manager, Graphic Design is a self-directed SME for labeling artwork management and control systems. This position determines how best to manage multiple projects and tasks to meet challenging, shifting timelines to support Eisai products packaged and/ or launched at external sites. Extensive industry experience and independent decision making is necessary to define, facilitate and/or customize cGMP compliant pharmaceutical labeling artwork procedures and systems to manage ethical drug product labeling requirements for US and ROW country specific product packaging within project specific labeling formats that involve multiple levels of complexity. Responsible for management of contract service providers (proofreaders and back-up graphic designer ) any additional graphics service providers that may be needed to support trade labeling. The Manager, Graphic Design stays abreast of and conversant in current pharmaceutical labeling artwork trends, requirements, best practices, and new technology relevant to product labeling. Collaborates with other functional groups within the company and maintains membership in industry-related packaging organizations such as IOPP/PmDLC to understand industry trends and best practices. May participate in industry group meetings, forums and cross-company benchmarking efforts. Essential Functions: • Creation, development and control of pharmaceutical labeling artwork for contractor-packaged prescription drug products. Collaborates directly with Supply Operations, Contract Manufacturing Operations (CMOs), multiple external contract packaging sites, country specific Global Regulatory Affiliates, Marketing, Technical Operations, Quality Assurance, and Corporate Alliance Partners to provide high quality, regulatory compliant labeling artwork for commercial products managed by Eisai Raleigh site., • Facilitates communication between cross-functional teams to support end-to-end labeling and timely implementation of regulatory updates., • Provides pharmaceutical product labeling artwork to meet critical path deadlines for new US and ROW product launches and / or submissions to the FDA and other country specific regulatory authorities, to facilitate global product launch initiatives., • Collaborates with Technical Operations during development of new packaging components for launch or line changes and develops test component artwork to support package line initiatives., • Strengthens and maintains cGMP compliant procedures for prescription pharmaceutical labeling artwork control and approval. Collaborates with management of affected departments to ensure cohesive working relationships and to meet shared objectives., • Management of contract service providers for support of labeling artwork procedures & systems to maintain and control current and retired FDA approved labeling artwork files., • Management of contract design services as needed to support high volume critical path projects. Requirements: • Bachelor's degree in graphic design, • 1-year related work experience in the pharmaceutical industry., • High skill level and understanding of design programs on Macintosh platform. Direct experience with Adobe Creative Cloud required., • Knowledge and experience with labeling security and serialization features., • Understanding of and direct experience with cGMP and FDA Regulatory prescription pharmaceutical labeling requirements., • Understanding of and direct experience with ROW, Canada, and emerging market country-specific labeling artwork requirements., • Ability to work independently and effectively, prioritizing assignments without supervision., • Highly developed interpersonal skills are required to effectively deal with all levels of personnel from executives to non-exempt and outside vendors., • Ability to exercise independent judgment and initiative on labeling matters., • Demonstrated initiative, results oriented, willingness and ability to institute change., • Process oriented with a strong interest in continuous improvement. #LI-MI1 Eisai Salary Transparency Language: The annual base salary range for the Manager, Graphics Design - Remote is from :$102,300-$134,300 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

Job Title: Customs Entry Writer Job Summary: We are seeking a detail-oriented Customs Entry Writer to join our logistics team. This role is responsible for preparing and submitting import documentation to U.S. Customs and Border Protection (CBP) to ensure timely clearance of international shipments. The ideal candidate will have experience in customs brokerage or freight forwarding, strong knowledge of import regulations, and the ability to manage multiple shipments in a fast-paced environment. Key Responsibilities: • Prepare and submit customs entries through ABI in accordance with CBP regulations, • Review commercial invoices, packing lists, bills of lading, and other import documents for accuracy and compliance, • Classify imported goods using the Harmonized Tariff Schedule (HTS) and determine applicable duties, taxes, and fees, • Communicate with importers, freight forwarders, carriers, and government agencies to obtain required documentation and resolve entry issues, • Monitor shipment status and coordinate cargo release with CBP and other regulatory agencies (FDA, USDA, EPA, etc. when applicable), • Maintain accurate records of import transactions and ensure compliance with company and government regulations, • Research and resolve customs holds, exams, and documentation discrepancies, • 2+ years of experience in customs brokerage, freight forwarding, or import operations, • Knowledge of U.S. Customs regulations and the Harmonized Tariff Schedule (HTS), • Experience filing entries through ABI and working with customs brokerage software, • Strong attention to detail and ability to manage high-volume entry processing, • Excellent communication and organizational skills, • Proficiency in Microsoft Office, especially Excel

The Department of Radiology at the Vagelos College of Physicians and Surgeons, part of Columbia University Irving Medical Center, is seeking a clinical diagnostic medical physicist to join our clinical medical physics group, which provides diagnostic imaging physics services to NewYork-Presbyterian Hospital and offsite locations. Join a collegial team and play a significant role in advancing medical imaging at one of the nation's top academic medical centers. The successful candidate will report directly to the Chief of Medical Physics. Salary range is$130,000 - $200,000. Compensation and academic rank will vary based on credentials, expertise, and experience. Columbia offers a generous benefits package, including college tuition and childcare reimbursement, tuition exemption for faculty members who wish to pursue graduate programs, generous retirement plans, and excellent health and dental coverage. Columbia University Irving Medical Center consists of a main campus with a 1300-bed hospital located in Manhattan, a community hospital, and several satellite medical offices. The imaging equipment consists of 21 MRI units, 20 CT scanners including 5 PET/CTs and 3 SPECT/CTs, 23 special procedures suites, 37 fixed radiography and R/F rooms, 10 digital mammography units, and a large number of mobile radiographic, mobile fluoroscopy, and ultrasound units. In total, there are more than 225 X-ray tubes. The diagnostic radiology physics group is comprised of 2 PhDs and 4 MS-level physicists, as well as two medical physics assistants. ACR accreditation is maintained for mammography, MRI, ultrasound, nuclear medicine, PET, and CT. Most of the equipment and facilities have recently been modernized. Job Responsibilities: • Conduct acceptance testing, periodic diagnostic x-ray equipment testing, and quality assurance surveys across a wide range of modalities, including CT, mammography, general radiography, fluoroscopy, MRI, and ultrasound., • Oversee radiographic technologist QA programs, PDM QA review, and contribute to ACR accreditation for CT, mammography, MRI, and ultrasound., • Prepare and maintain equipment testing records to comply with regulatory standards from NYC-DOH, NYS-DOH, MQSA, FDA, TJC, ACR, and other pertinent bodies., • Provide guidance on CT and MRI imaging protocol optimization, CT dose tracking, and MRI safety practices, including evaluation of MR-conditional devices and site safety audits., • Engage in educational activities, teaching radiology residents, and training healthcare staff on, e.g., phantom scans related to equipment quality assurance., • Collaborate with other departments and liaise with inspectors and regulators to maintain compliance and excellence in diagnostic imaging services. Education and Experience: • MS or PhD in medical physics, radiological physics, or a related field., • Preferred Mammography MQSA certification., • Having, or being eligible for, NYSED licensure in diagnostic radiological medical physics., • Clinical experience in diagnostic imaging quality assurance, preferably in a university hospital setting., • Extensive experience with a wide range of radiology imaging equipment, including CT, mammography, general radiography (CR/DR), fluoroscopy (II/FPD), MRI, and ultrasound., • In-depth understanding of the rules, guidelines, and standards of regulatory and accrediting bodies., • Exceptional communication skills in all means of communication, capable of effective interaction at all levels of hospital staff across a multitude of departments., • Board certification in diagnostic medical physics by the American Board of Radiology (ABR)., • If not already NYS licensed, must obtain NYS licensure in diagnostic medical physics within 6 months of starting. The above salary range represents Columbia's good faith and reasonable estimate of possible compensation at the time of posting. Columbia University is an Equal Opportunity Employer / Disability / Veteran Pay Transparency Disclosure The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

Experienced Clinical Research Associate - Full-Service Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities • Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes., • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues., • Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements., • May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned., • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations., • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution., • For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets., • May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements, • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements., • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. Qualifications: • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience, • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements, • Must demonstrate good computer skills and be able to embrace new technologies, • Excellent communication, presentation and interpersonal skills, • Ability to manage required travel of up to 75% on a regular basis, • US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

The Department of Radiology at Columbia University Irving Medical Center/NewYork-Presbyterian is seeking a full-time nuclear medicine radiologist to join our growing Division of Nuclear Medicine. This is a great opportunity for a clinician-scientist with ambition to grow a career in research and administration. Compensation and academic rank will vary based on credentials, expertise, and experience.Salary range starts at$400,000(for a faculty member in the first year out of fellowship). Columbia University offers a generous benefits package. This position has been created to accelerate the clinical, academic, and research program in Molecular Imaging and Therapy at Columbia. Physicians with a track record or demonstrable strong interest in translational molecular imaging will be preferred. The successful candidate will independently cover a busy service when on clinical rotation and actively lead a research program after a startup period, where dedicated research time and resources will be made available. We provide active mentorship from departmental leaders. Other responsibilities include participation in resident and fellowship education, participation in interdisciplinary conferences, and collaboration with clinical colleagues. The PET Center imaging resources include 3 state-of-the-art PET/CT scanners, available for clinical and research use. Dedicated research facilities include a Molecular Imaging Center that houses 2 cyclotrons, 3 PET/CT cameras, and a cGMP facility capable of production of radiopharmaceuticals for research/clinical use, along with a dedicated regulatory office to expedite FDA approval. Modifications to the facility to enable cGMP production of compounds suitable for MR imaging/spectroscopy are feasible. The Division faculty interpret over 3,000 PET/CT scans and perform almost 500 research imaging cases annually. We work in partnership with colleagues in the medical center's many highly regarded departments and centers, including the renowned Gertrude H. Sergievsky Center for the investigation of diseases of the central nervous system, the Taub Institute for research on Alzheimer's disease and the aging brain, the Department of Neurology, the Cerebrovascular Center of the Neurological Institute, the Department of Neurological Surgery, the NCI-designated Herbert Irving Comprehensive Cancer Center, the Department of Radiation Oncology, the Department of Psychiatry, the New York State Psychiatric Institute, and the Department for Biomedical Engineering. The Department of Radiology at Columbia University Irving Medical Center has more than 100 full time faculty and performs over 800,000 imaging exams each year in state-of-the-art facilities that extend from northern Westchester to New York City. Our hospital, New York-Presbyterian, is a tertiary and quaternary care center ranked as one of the best in the country and New York City, treating a wide range of patients from the NYC tristate area and across the world. Columbia University is an exciting hub of innovation and technology, with many opportunities to collaborate with other departments and schools. Columbia University offers a highly competitive benefits package, including college tuition and childcare reimbursement, tuition exemption for faculty members who wish to pursue graduate programs, generous retirement plans, and excellent health and dental coverage. Continuing Medical Education/conference days are apportioned by academic rank and are negotiable to fit candidate needs. More information about the department can be found on the Columbia Radiology website. Please reach out with any questions to: Noor Ahmad, MD, Vice Chair of Clinical Operations at . The position requires a Nuclear Radiology fellowship-trained diagnostic radiologist or board certification in nuclear medicine. The candidate must be fellowship trained in nuclear medicine and preferably board certified in both Diagnostic Radiology and Nuclear Medicine and must also be eligible to practice medicine in the State of New York. Columbia University is an Equal Opportunity Employer / Disability / Veteran Pay Transparency Disclosure The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

Prepare and maintain 510(k) submissions and other required regulatory filings, where applicable. Oversee product registrations, technical documentation, and regulatory records. Monitor evolving FDA, FTC, and other relevant regulatory requirements and provide practical guidance to internal stakeholde

Quality Systems Director – Permanent – New York Proclinical is seeking a Quality Systems Director for an emerging biotech company based in New York. Primary Responsibilities: In this role, you will be responsible for the hands-on oversight of all Quality Assurance (QA) Good Manufacturing Practices (GMP) activities pertaining to the manufacture of drug product, analytical, packaging, labeling, distribution, and release of Clinical Supplies. You will own and lead the CMC Quality function across internal operations and external partners (CMOs/CROs/contract laboratories), including batch disposition, quality systems, change management, deviations, investigations, complaints, audits, and product release activities. The position is based onsite in New York. Skills & Requirements: • B.S. or B.A. or higher degree (preferably in Life Science) with 10+ years of hands-on experience with increasing responsibility as a Quality Assurance Professional., • Experience in small molecule development, batch release, and SOP drafting., • Hands on experience implementing quality management systems in a GxP environment, and direct experience with FDA and other health authority inspections., • Strong understanding and extensive knowledge of industry practices and global regulatory requirements (FDA, EMA, ICH) for clinical-stage products., • Proven ability to build or scale quality systems in a dynamic environment., • Prior experience managing CDMOs and external quality oversight strongly preferred., • Experience in supporting IND/CTA/IMPD submissions and clinical supply release preferred. The Quality Systems Director will: • Author, review and approve Standard Operating Procedures (SOPs), protocols, reports, specifications and other quality records for accuracy and compliance with all applicable regulations, guidance, and international standards., • Review and provide quality input for CMC sections of product registration applications, and Investigational Medicinal Product Dossier (IMPD) submissions for drug substance, drug products analytical methods and stability studies., • Develop and execute the CMC QA strategy aligned with company goals and regulatory expectations., • Build, refine, and scale quality systems appropriate for a fast-growing biotech (e.g., change control, deviations, CAPA, document control, supplier management)., • Serve as the primary QA point of contact for CMC, manufacturing, analytical development, supply chain, and regulatory teams., • Build and oversee cGMP Quality Management Systems, Batch Review and Release, Quality Control testing activities and disposition of packaging products to ensure compliance with internal procedures and global regulatory requirements (e.g., FDA, EMA, ICH).Manage quality audits at CMOs, CROs, contract labs including the implementation and monitoring of audit related corrective and preventative actions (CAPAs)., • Lead and facilitate thorough cGMP investigations for process deviations, out of specification test results, Out of Tolerance, and Out of Specifications events and identify root cause and CAPAs. Provide Quality Assurance input for failure analysis, problem solving, and risk assessment and mitigation activities related to the qualification and validation of the cGMP facility and equipment. If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.

Quality Manager Needed For Leading Manufacturing Company This Jobot Job is hosted by: Kevin Finlay Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume. Salary: $100,000 - $130,000 per year A bit about us: My client is a leading manufacturing company who is actively growing! They are looking to add a Quality Manager to their team to lead our quality assurance initiatives and enhance our operational standards. Why join us? Benefits: • Competitive salary with performance-based bonuses and salary reviews., • Comprehensive health, dental, and vision insurance plans., • Generous retirement plan options, including company matching contributions., • Paid time off and flexible work arrangements to help maintain a healthy work-life balance., • Opportunities for professional growth, training programs, and conferences. Job Details Key Responsibilities: • Formulate, document, and execute comprehensive quality assurance policies and procedures tailored to meet industry-specific standards., • Design and lead quality improvement programs that focus on reducing defects and enhancing product reliability, collaborating with cross-functional teams to align quality goals with business objectives., • Lead, mentor, and manage a diverse team of quality assurance specialists, fostering an environment of continuous learning and improvement., • Conduct regular workshops and training sessions on emerging QA methodologies, tools, and compliance regulations to ensure the team remains proficient in current practices., • Oversee the creation and implementation of rigorous testing plans and protocols, ensuring they are executed effectively to validate product performance and safety., • Conduct regular audits of production processes, employing statistical process control to pinpoint inefficiencies and facilitate corrective actions., • Analyze quality metrics and performance data, generating detailed reports that provide insights into trends, root causes of issues, and areas for improvement., • Utilize advanced data analysis software to create dashboards and visual representations of quality data for executive presentations., • Ensure that all QA activities and documentation comply with industry regulations such as ISO 9001, FDA, or other relevant standards., • Bachelor’s degree in Engineering, Quality Assurance, or a related field; a Master’s degree is highly desirable., • A minimum of 7 years of experience in quality assurance management,, • Comprehensive knowledge of quality management systems (QMS), methodologies, and relevant regulatory requirements (e.g., ISO standards, Good Manufacturing Practices)., • Proficient in data analysis tools, statistical methods, and quality improvement techniques such as Six Sigma or Lean Manufacturing. Interested in hearing more? Easy Apply now by clicking the "Apply" button. Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: jobot.com/privacy-policy

Medical Device Leader! Principal Quality Engineer Opportunity! This Jobot Consulting Job is hosted by: David DeCristofaro Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume. Salary: $65 - $85 per hour A bit about us: We are a leading medical device company that operates privately and is committed to enhancing the care and quality of life of patients with kidney disease. Our goal is to create cutting-edge solutions that enable patients and their healthcare providers to manage kidney disease with ease. Why join us? • Company Equity!, • Excellent medical, dental, & vision package!, • 401(k) with a match!, • Generous PTO!, • Opportunity to make a difference in people's lives! Job Details We are seeking a dynamic and experienced Principal Quality Engineer to join our team. This role will be responsible for leading the quality engineering initiatives ensuring ongoing safety, efficacy, and compliance of medical devices as they enter the market. The ideal candidate will have a strong background in quality engineering within the Medical Device industry, with a focus on FDA regulations, ISO 13485, CAPA, and other regulatory and compliance requirements. Responsibilities: 1. Lead the development and implementation of quality systems in compliance with FDA and ISO 13485 regulations., 2. Analyze and manage Corrective and Preventive Actions (CAPA) to ensure effective resolution of quality issues., 3. Utilize problem-solving methodologies such as Fishbone or DMAIC to identify root causes and implement corrective actions., 4. Maintain the FDA Quality Management System Reporting (QMSR) and ensure that all quality metrics are met or exceeded., 5. Provide consultation to various departments on quality systems, regulatory compliance, and risk management., 6. Conduct internal and external audits to ensure compliance with regulatory standards., 7. Lead and oversee post-market surveillance programs., 8. Collaborate with cross-functional teams to drive continuous improvement initiatives., 9. Lead the review and approval of design and process changes, ensuring compliance with quality standards and regulatory requirements. Qualifications: 1. Bachelor's degree in Engineering, Quality Assurance, or a related field is required., 2. Minimum of 12 years of experience in a quality engineering role with strong medical device industry experience., 3. Extensive knowledge of FDA regulations, ISO 13485, Fishbone, DMAIC, 8D, and/or FDA QMSR., 4. Expertise in post-market quality system activities including complaint handling, vigilance/adverse event reporting, HHE, and post-market surveillance., 5. Conduct and lead complex investigations and implement CAPA., 6. Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) is preferred. Interested in hearing more? Easy Apply now by clicking the "Apply" button. Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: jobot.com/privacy-policy

About Ogilvy Ogilvy, part of WPP, has been creating impact for brands through iconic, culture-changing, value-driving ideas since the company was founded by David Ogilvy 75 years ago. It builds on that rich legacy through Borderless Creativity - innovating at the intersections of its advertising, public relations, relationship design, consulting, and health capabilities with experts collaborating seamlessly across over 120 offices in nearly 90 countries. Ogilvy currently ___ as the #1 global agency network for creative excellence and effectiveness by WARC, signifying its ability todeliver creative solutions that drive unreasonable impact for clients and communities.Ogilvy is a WPP company (NYSE: WPP). For more information, visit___, and follow us on , About WPP WPP is the trusted growth partner for the world's leading brands. We unitecutting-edge media intelligence and data solutions, world-class creativity, next-generation production, transformative enterprise solutions and expert strategic counselin a single company -powered by exceptional talent and our agentic marketing platform, WPP Open,to help our clients navigate change, capture opportunity and deliver transformational growth. For more information, visit___. OGILVY HEALTH: WE INSPIRE PEOPLE AND BRANDS TO IMPACT THE WORLD Guided by this vision, Ogilvy Health, part of WPP, combines borderless creativity, scientific precision and cultural fluency to build healthcare's most influential movements. We drive measurable impact and category-defining growth for brands ready to shape what's next. Our approach is powered by fearless creativity that dares to be different, sparks emotional connections, and inspires action, ensuring cultural resonance. Scientific precision translates complex data into stories that resonate, while our impact-obsessed mindset focuses on delivering real-world outcomes. For more information on us, visit___, or follow Ogilvy Health on___,,. About The Role We are looking for a dynamic, flexible, and experienced Group Creative Director to champion modern creativity, uniting earned, social and influence, within health. This role goes beyond the standard adaptation of marketing and advertising campaigns for PR and social use. It is about conceiving and executing groundbreaking creative ideas that are inherently designed to generate attention, conversation, and advocacy offline and online. You will lead a team of talented creatives, inspiring them to think beyond paid media and embrace the power of authentic engagement to build brand love and drive health outcomes. What You'll Do • Visionary Leadership:Define and champion the agency's "earned first " creative philosophy, ensuring it is integrated into all relevant client strategies and creative development processes., • Creative Direction & Excellence:Lead the development and execution of innovative, high-impact culture-first creative campaigns and concepts that are strategically sound, socially relevant, and designed for channel-specific organic amplification offline and online., • Team Leadership & Mentorship:Manage, mentor, and inspire a team of earned creatives (copywriters, art directors, content creators, community managers) to push creative boundaries and deliver exceptional work. Foster a collaborative and innovative team environment., • Strategic Partnership:Collaborate closely with strategy, account, social and influence, and media teams to ensure creative concepts are aligned with client objectives, audience insights, and omnichannel best practices., • New Business Development:Drive new business pitches, showcasing the agency's expertise in earned, social and influence-led creativity, championing a nimbler and trend-forward approach to creative, and helping to secure new clients., • Client Relationship Management:Present and defend creative concepts to clients, building strong relationships and acting as a trusted advisor on earned social strategies., • Trend Spotting & Innovation:Stay at the forefront of trends, creators, emerging platforms, and best practices in earned and social media. Proactively identify new opportunities for clients and the agency., • Campaign Strategy & Development:Oversee the development of dynamic campaigns from concept to creation, including an understanding of diverse content formats optimized for social platforms, short-form video, long-form video, activation moments, interactive content, influencer collaborations, and community-driven initiatives., • Performance & Optimization:Work with analytics teams to understand the performance of campaigns, identify insights, and optimize creative for maximum earned impact., • 10 years of progressive experience in creative roles within a PR, social, advertising or marketing agency, with at least 3-5 years specifically focused in Healthcare, • Proven track record of developing and executing highly successful "earned first" campaigns that generated significant organic impact., • Strong understanding of both the healthcare industry and the creator economy, the regulations (e.g., FDA, HIPAA, FTC), and the unique challenges and opportunities of communicating this information., • Exceptional leadership and team management skills, with a passion for mentoring and developing creative talent., • Deep expertise across earned media (traditional media and creator brands) and major and emerging social media platforms (TikTok, Instagram, X, Facebook, LinkedIn, Reddit, YouTube, etc.) and a keen understanding of their audience behaviors., • Proficiency in various content creation tools and platforms (e.g., Adobe Creative Suite, video editing software)., • Excellent presentation, communication, and interpersonal skills, with the ability to articulate creative vision and strategy effectively to clients and internal teams., • Strategic thinker with a strong analytical mindset, able to translate data and insights into actionable creative solutions. Ogilvy celebrates its people. Fully. Enthusiastically. Unhesitatingly. We'll empower you with the tools you'll need to succeed. We'll give you the autonomy to seek out new paths and better ways of doing things. We'll support you with colleagues who are experts in their disciplines, drawn from across the Ogilvy network. And we'll provide opportunities for you to do work of which you'll be proud, with people you'll be proud to call your teammates. #LI-SH The base salary range for this position at the time of this posting is indicated below. Individual compensation varies based on job-related factors, including location, business needs, level of responsibility, experience, and qualifications. We offer a competitive benefits package, click ___ for more details. Pay Range$125,000—$295,000 USD At Ogilvy, our people are at the heart of what we do: a creative agency that sparks game-changing ideas across culture and business through collaboration, integrity, and a celebration of self-expression. We believe in building powerful teams with purpose - and we relentlessly curate transformative initiatives that make our commitment to fairness, and equity a reality. Our ultimate mission is to leave a positive impact on the world, creating a better future for all, while supporting and uplifting the global communities we serve. This is central to our mantra of Borderless Creativity. Ogilvy is an equal opportunity employer and considers applicants for all positions without discrimination or regard to particular characteristics. We are committed to fostering a culture of respect in which everyone feels they belong and has the same opportunities to progress in their careers. If you need any assistance seeking a job opportunity, or if you need reasonable accommodation with the application process, please contact us at . Please note that this contact is only for candidates who are requesting accommodation. Emails for other purposes, including application status requests, will not receive a response.

This involves working with life sciences clients to develop business processes, and design and implement systems to effectively manage these areas governed by the FDA and similar regulatory bodies globally:Quality Management Systems (including complaint management, CAPAs, deviations, change control,

Additional responsibilities include: Advise suppliers, biotechnology, and pharmaceutical companies on FDA regulatory compliance matters Counsel health systems and healthcare providers on reimbursement issues, fraud and abuse laws, and healthcare regulatory compliance programs Provide strategic guida

A public pharmaceutical company in New York seeks an experienced FDA Regulatory/Commercial lawyer to serve as Assistant General Counsel. Candidates should have a JD, 10+ years of experience in pharmaceutical law, and strong analytical and communication skills.

My client, a Global Healthcare Manufacturer is experiencing a time of rapid growth and is therefore looking to hire a talented Assistant General Counsel. Reporting into the General Counsel, this individual will support various areas of the business, but with an emphasis on FDA/EPA/FTC regulatory law

Job DescriptionPharmacist in Charge About PersonalRx 🌐 PersonalRx is a patient-first, service-driven pharmacy dedicated to improving lives through personalized medication management and reliable home delivery. By combining technology, clinical expertise, and regulatory excellence, we ensure every prescription is filled accurately and on time. Join our growing team and help shape the future of pharmacy care. Position Overview PersonalRx is seeking an experienced and motivated Pharmacist in Charge to lead our East Rutherford, New Jersey pharmacy operations. This role carries full accountability for regulatory compliance, pharmacy operations, and team performance while maintaining a strong focus on patient-centered care. The ideal candidate brings deep pharmacy operations experience, strong leadership skills, and a proactive approach to quality, compliance, and continuous improvement. Key Responsibilities * Serve as the designated Pharmacist-in-Charge (PIC)/ with full accountability for pharmacy operations * Ensure compliance with all New Jersey Board of Pharmacy, state, and federal regulations, including DEA, Medicare, and Medicaid requirements * Lead, mentor, and support a team of 5–10 pharmacists and pharmacy technicians * Partner with the Operations Manager to streamline workflows, improve productivity, and maintain exceptional service levels * Collaborate with executive leadership on strategic initiatives, service expansion, and operational improvements * Manage pharmacy inventory, including procurement, storage, and controlled substance accountability * Oversee quality assurance programs, audit readiness, and continuous process improvement initiatives * Serve as the primary contact for regulatory inspections, audits, and third-party payer reviews * Evaluate, implement, and oversee pharmacy technology systems; ensure staff training and compliance * Resolve escalated patient issues while maintaining a high standard of patient-centered care Qualifications * Doctor of Pharmacy (PharmD) or equivalent degree from an accredited institution * Active, unrestricted New Jersey pharmacist license (required) * Minimum 5–7 years of pharmacy operations experience, including 2+ years in a PIC or leadership role * Strong knowledge of USP, DEA, FDA, and NJ State Board of Pharmacy regulations * Proven experience managing teams and workflows in a complex pharmacy environment * Proficiency with pharmacy management systems and related software * Excellent communication, organizational, and leadership skills * Demonstrated commitment to patient safety, quality, and service excellence Preferred Qualifications * Experience in specialty, long-term care, or mail-order pharmacy * Familiarity with Medicare Part D and third-party payer processes * Strong analytical, reporting, and process-improvement skills Compensation & Benefits * Competitive salary: $135,000 – $150,000 (commensurate with experience) * Paid time off and paid holidays * Professional development support and continuing education reimbursement * Collaborative, mission-driven work culture Why Join PersonalRx? At PersonalRx, you’ll have the opportunity to make a meaningful impact every day—enhancing medication safety, improving patient outcomes, and leading a talented pharmacy team in a supportive, growth-oriented environment. Apply today! A member of our leadership team will review your application promptly. PersonalRx is an EOE Powered by JazzHR 5L1wi41I2r

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description Facilitates information exchange, education, and research activities for physicians and ancillary healthcare professionals regarding current and future therapies in development or commercialized by Allergan Aesthetics. Provide scientific expertise and serve as a point of contact for both external and internal leads in PRM. Gather and provide scientific insights to inform global strategic planning for PRM. Additional activities, special projects and assignments may be given, as required. As a result, the percentage of time spent across key duties and responsibilities will vary depending on project assignments and therapeutic area needs. Domestic and limited international travel will be required. External Relationships • Identify, establish, and maintain relationships with top tier thought leaders in the therapeutic area (TA) to establish a strong scientific presence in the clinical and academic communities. Ensure thought leader development and communication is optimized. Collaborate cross-functionally to establish scientific and clinical credibility with payers, managed market/market access and healthcare decision makers., • Provide meaningful and comprehensive external scientific communications both proactively and reactively, • Deliver assigned portfolio-related clinical presentations and participate in prioritized scientific meetings and congresses, • Execute Advisory Boards (face-to-face and virtual) based on scientific need and TA strategic plan, • Support global strategic plan country level scientific education needs including scientific exchange meetings, • Contribute to the review of research proposals and publications, • Contribute to the creation of materials and content used in scientific communications, • Scientific training of cross-functional hires as needed Strategic and Tactical Planning • The Senior Medical Science Liaison II serves as a scientific resource to support internal MSL and cross-functional scientific training, • Functions as a peer leader in exemplifying outstanding execution of the Senior Medical Science Liaison II role and acts as a key strategic field resource to internal Medical Affairs partners., • Contribute to the development and are directly responsible for the implementation of the TA Medical Affairs strategic and tactical plans:, • Deliver and communicate progress on project milestones, • Contribute to the planning and direct execution of broader functional activities that support the TA strategic plan, • Support assigned Core Teams within the TA as needed:, • Contribute to assigned sub-teams, • Represent TA on Clinical teamsQualifications, • PhD in an aligned field, or MD degree from an accredited US or foreign medical school with postgraduate medical training:, • MSL industry experience required, • Proven track record of success in medical affairs role Essential Skills and Abilities • Must have a working understanding of legal and regulatory guidelines (e.g., OPDP promotional regulations, Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws and other local applicable regulations), • Familiar with Medical Affairs principles, study design and scientific publications, • Proficient with electronic systems including Microsoft Office Suite, SharePoint, videoconferencing platforms, • Ability to prioritize and manage multiple projects, • Self-starter with ability to work independently with remote supervision, • Ability to work effectively in a team/matrix environment, • Ability to influence others without direct reporting relationships, • Ability to travel as required, • Demonstrated strengths in the following areas:, • Planning, organizational, project management and analytical skills, • Oral and written communication, • Time management, • Negotiation, • Conflict management and resolution, • Problem solving, • Attention to detail, • Interpersonal and networking skills, • Motivational skills, • Cross-cultural sensitivity, • Customer service orientation Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more orless than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidand may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job Description Role Summary You will lead and manage biostatistical activities across a complex portfolio of gene therapy studies and other projects. You will collaborate with cross-functional partners to meet clinical development project deliverables and timelines. This may include, but is not limited to, providing statistical consultation on clinical development plans, clinical trial design and clinical study endpoints, calculating sample size, authoring statistical analysis plans, and providing biostatistical input into clinical development plans, scientific publications and presentations, and regulatory filings. You will be responsible for the analysis of interim and final data sets and will oversee data and programming deliverables accountable by the CRO. A remote working model may be considered for exceptional candidates. Primary Responsibilities • Author statistical analysis plans in conjunction with the clinical team, • Responsible for biostatistical activities for a complex portfolio of clinical studies for gene therapy programs., • Where applicable, oversees and directs statistical analysis, document review and data inclusion for NDA submissions of assigned studies by collaborating with own team, other Biostatistics team members, CROs, and cross-functional partners. Ensures appropriate statistical consultation on trial design and study endpoints and timely and well-executed authoring of statistical analysis plans., • Align the requirements for data reporting, tables, listings, and figures required for interim and final reports, including topline reports and final clinical study reports., • Where applicable, oversees, and contributes to completion of all technical and operational statistical activities for a portfolio of clinical trials. Directs internal and external teams in the definition, execution and completion of statistical activities for disease or therapeutic area products of considerable complexity., • Contribute to clinical study designs and clinical development planning for the portfolio., • Where applicable, advises or otherwise ensures timely and appropriate advice to internal and external partners on statistical analysis strategies, reliability of measurements and identifiability of models, and interpretation and presentation of statistical results., • Ensures timely and appropriate gathering, organization, and analysis of different data sources to enable delivery of the statistical analysis plan and clinical study endpoints for clinical studies., • Reviews and approves biostatistical input into clinical development documentation, scientific publications and presentations and regulatory documentation., • Typically takes a lead in special projects that can benefit multiple biostatistics team members, such as new methodologies, processes, technology and other tools, and may also lead the development and / or implementation of SOPs and related documentation., • Provide statistical leadership in clinical study team setting., • May independently present at department, project team, or Sr. Management meetings., • Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and LEXEO’s SOPs. Required Skills and Qualifications, • PhD in biostatistics or related discipline with 8+ years (10+ years with MS) relevant experience in statistical analysis of biomedical data using SAS or equivalent software in the biopharma industry or a related environment, • Extensive biomedical statistical analysis experience and experience working with relevant software., • Experience developing software and other tools to support statistical analysis of biomedical or related data. Strong proficiencies in software and other tools used typically used by Biostatistics., • Demonstrated excellence in complex project management and effectively managing multiple projects and priorities., • Experience working with CROs for data and programming deliverables., • Experience leveraging AI and machine learning to enhance clinical trial design, analyses and decision-making is preferred., • Expert-level of knowledge of biostatistics, as evidenced by independence in assuming responsibilities for complex Phase 1-3 gene therapy projects., • Extensive knowledge of statistical designs, applicable to clinical trials in rare disease which allow for robust study results in smaller datasets., • Demonstrates strategic thinking in advising others on statistical requirements and opportunities to improve study or other project outcomes., • In-depth understanding of the cross-functional roles and responsibilities involved in drug development., • Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures., • Strong communication and organizational skills., • Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives, and steering committees., • Ability to handle multiple development programs simultaneously., • Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills., • Excellent written and verbal communication skills demonstrated by ability to present clear instruction/direction., • Analytical and problem-solving capabilities., • Collaborative and collegial work style.

Job DescriptionJob Title: REMOTE Territory Sales Manager – Specialty Chemicals & APIsCompensation: $100,000–$130,000 base + performance incentives Location: Remote (U.S.) Industry: Specialty Chemicals / APIs / Pharmaceutical Intermediates Overview A global manufacturer of specialty chemicals and pharmaceutical ingredients is expanding its North American commercial team. This is a high-impact sales role focused on growth within key verticals including iodine derivatives, intermediates for anti-cancer and contrast media, and active pharmaceutical ingredients (APIs). The role is modeled on a proven sales structure used for similar markets, emphasizing relationship management, business development, and strategic positioning across nutraceutical, pharma, and fine chemical sectors. Key Responsibilities * Drive sales growth across the North American territory for specialty and pharmaceutical-grade chemical ingredients. * Identify, target, and close new business opportunities across the following categories: * Iodine derivatives * Anti-cancer drug intermediates * X-ray and contrast media intermediates * APIs and stomach-related APIs * Develop and maintain relationships with key accounts, distributors, and manufacturers. * Collaborate closely with global production and regulatory teams to ensure compliance and delivery. * Analyze market trends and identify high-value prospects for long-term partnerships. * Represent the company at key trade shows and industry events (e.g., IBIE, CPhI, SupplySide West). * Prepare detailed reports and forecasts for executive management. Qualifications * Bachelor’s degree in Chemistry, Chemical Engineering, or related field (advanced degree a plus). * Minimum 5 years of experience in B2B sales of specialty chemicals, APIs, or pharmaceutical intermediates. * Proven track record of achieving revenue goals and building strategic partnerships. * Familiarity with regulated markets (FDA, REACH, GMP) preferred. * Exceptional communication, negotiation, and presentation skills. * Self-motivated, entrepreneurial mindset; able to operate with minimal supervision. Compensation & Benefits * Base salary between $100,000 and $130,000, depending on experience. * Performance-based commission and annual bonus structure. * Health coverage, paid time off, and travel reimbursement. * Long-term growth opportunity with a global chemical leader expanding in the U.S. market.

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . Description: The R&D Engineer I/II is responsible for supporting product design and process development activities while ensuring compliance with all quality and regulatory requirements. The position has a scientific focus that includes implementation of formulation development through process development, prototype fabrication, and characterization, along with additional process evaluation and data generation through designed experiments. Process development in an R&D environment will be followed by qualification and technology transfer into manufacturing. Collaboration is a key aspect of this role, as the engineer will work within a multidisciplinary team of researchers and engineers. The position offers diverse opportunities in a collaborative cross-functional environment, requiring adaptability, flexibility, and a willingness to learn and innovate in the exploration of new technologies, new approaches, and techniques in pursuit of product/process robustness and innovation. The R&D Engineer I/II is expected to possess expertise in areas including, but not restricted to, polymer, chemical, material science, and process development and engineering. Additionally, they will assist in generating documentation essential for regulatory submissions, ongoing publication initiatives, and direct communication with the Head of Research regarding various tasks. This is a full-time, on-site position, located in Brooklyn, New York. This role is an independent contributor role (i.e. no direct reports). Level is dependent on experience. Responsibilities: • Oversee the planning, implementation, and analysis of experiments relevant to project objectives. Ensure the application of established scientific and engineering principles to solve complex problems and challenges innovatively and efficiently, adhering to rigorous scientific methodologies and protocols., • Create and execute product/process enhancement, and new product/process development plans., • Lead material/design/process changes and their implementation with well-documented research/analyses. Process and analyze results,, • Author protocols and reports including engineering studies and design verification/validation activities., • Aid in the development and execution of testing methods to aid in exploratory research, product/process development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes., • Prepare samples as required for manufacturing, testing, or other evaluations and data analysis., • Participate in voice-of-customer (VOC) labs and other user needs assessments., • Interface with external vendors, customers, and suppliers. Specify equipment and process requirements for developing and implementing new products, product improvement and new equipment/processes., • Support process and product transfers to manufacturing or CDMOs., • Maintain a laboratory notebook and other technical documentation according to required GLP/GMP guidelines., • Understand and prioritize process improvements, design experiments to make those improvements, and execute these plans in the laboratory., • Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation about research towards FDA/regulated authority submissions., • Provide support to the marketing and sales team, with the development of presentations, sales tools, and application data., • Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. Required Qualifications • Education: BS in Chemical Engineering, Polymer Engineering, Material Science & Engineering, or related engineering discipline., • Minimum 4+ years previous experience in an industrial environment with a BS degree. (2 years minimum experience if advanced degrees)., • Proficiency as an adept experimentalist with hands-on experience in the product and process development of polymeric materials and their characterization in an R&D or manufacturing environment., • Mathematically inclined with strong analytical and problem-solving skills with the ability to be observant and to think creatively. Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. Demonstrated ability to work independently as well as be a strong team contributor. Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks., • Requires understanding of product/process design and engineering. Experience should include process development/validation and/or transfer/verification, protocols, and troubleshooting skills., • Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency on time., • Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills., • Working knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (cGMP) requirements., • Proficiency in the use of Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft PowerPoint is required., • Requires excellent written and verbal communication and presentation skills., • Legal authorization to work in the United States is required., • Physical Requirements include:, • Aseptic Gowning Qualification: Able to be successfully qualified for aseptic gowning, including successful respirator training., • Wear Appropriate Personal Protective Equipment (PPE):, • Be able to stand and walk for prolonged periods, with the ability to climb, balance, stoop, bend, reach, and handle equipment., • Ability to speak, listen, and understand verbal and written communication., • Possesses hand-eye coordination and manual dexterity for delicate manipulations., • Ability to lift up to 50 pounds occasionally and to carry, push, pull, or otherwise move objects., • Visual acuity is required for performing close and distant activities. Preferred Qualifications • An advanced technical degree (MS or PhD)., • ·Lab experience in an industry setting within cGMP-regulated environments., • Prior experience developing processes and scaling these up into manufacturing or CDMO, • Mechanical/electrical knowledge with the ability to troubleshoot processing equipment, • Six Sigma green belt or black belt certification preferred., • Experience implementing process and quality improvements in a manufacturing environment, • Work experience with the medical device or pharmaceutical industries, • Working knowledge of ISO 9001, ISO 13485:2003 and ISO 14971:200., • Working knowledge of FDA requirements as per 21 CFR 820. Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits • Competitive annual base salary range of $70,000 - $120,000, depending upon job level and qualifications, • Paid Vacation, Sick, & Holidays, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%, • Work/Life Employee Assistance Program, • Company Paid Life and Short-Term Disability Coverage, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . Description: The Senior Medical Device Engineer is responsible for leading the design and development activities of new products and improving existing products in compliance with all quality and regulatory requirements. They will be responsible for authoring technical documents for the development of medical devices and combination products according to relevant Design Control regulations and standards. The person in this position will also be responsible for providing project-specific support, including technical analysis and review of supplier documentation as required. The position has a scientific focus that includes formulation development, product performance characterization, and implementation, including prototype design and fabrication, and data generation through designed experiments. The Senior Medical Device Engineer is expected to aspire for excellence with a bias toward action, willing to roll up their sleeves, get hands-on, and do what’s necessary to move projects forward in a fast-paced environment. They are committed to designing and developing products that dominate the marketplace and improve healthcare by partnering with our customers to drive purposeful innovation, resulting in best-in-class products. The Medical Device Engineer will work with a multidisciplinary team of researchers. This is a multi-faceted job in a highly collaborative environment across multiple functions that will require flexibility as well as an ability to learn about and develop new technologies and explore new techniques in pursuit of product innovation and robustness. Role level is contingent on experience, but this is not an entry level role.. This is a full-time, on-site position, located in Brooklyn, New York. Responsibilities • Create and lead experimentation for exploratory and/or product development research focusing on polymeric materials devices and their use., • Define new product functional requirements (design inputs/user needs) and evaluate the design's overall effectiveness, cost, reliability, and safety., • Lead cross-functional teams to develop new products, address design issues, and maintain existing designs., • Apply strong problem-solving skills to find solutions to complex problems., • Work independently to plan and schedule own activities necessary to meet project timelines., • Work cooperatively with, quality, manufacturing, regulatory, clinical, and marketing to ensure project success., • Lead the creation of design history file documentation through the new product development process., • Develop new implant and instrument designs utilizing Solidworks and modeling/detail design specifications., • Generate technical protocols/reports to support device safety and efficacy., • Invent/create concepts and designs and submit invention disclosures., • Ensure that all design activities adhere to FDA Quality System Regulations and ISO 13485 design control and risk management requirements. Lead material/design/process changes through a design control process, with well-documented research/analyses., • Author protocols and reports including development studies and design verification/validation activities., • Develop and execute test methods to aid in exploratory research, product development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes., • Exercise technical judgment in the design, execution, and interpretation of experiments within the scope of project responsibilities and ensure the use of professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods and procedures., • Prepare samples as required for testing, or other evaluations and data analysis, including in voice-of-customer (VOC) labs., • Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication., • Maintain a laboratory notebook and other technical documentation to required GLP/GMP guidelines., • Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions,, • Provide support to marketing and sales team, support the introduction of new technologies with the development of presentations, sales tools, formulations, and applications data, • Communicate results to the scientific community via published papers. Present research at academic/industry symposia as an external representative of the company., • Manage part-time staff as a research leader and mentor for ongoing research projects., • Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization., • Provide other project or product support as needed in order to support Cresilon’s business objective. Required Qualifications • BS in Chemical Engineering, Polymer Engineering, Material Science, Biomedical Engineering, Mechanical Engineering, or related scientific discipline., • A minimum of 5+ years of product development experience is required., • A minimum of 4 years of hands-on experience in new product research and development in a cGMP-regulated industry is required (work experience in the Medical Device field is strongly preferred), • Adept experimentalist with hands-on experience in product development of medical devices and their safety/efficacy characterization in an R&D environment., • Experience gathering user needs, translating them to technical inputs, and developing viable V&V (Design Verification and Validation) plans., • Experience leading complex product development initiatives from concept through product launch/release., • Good working knowledge of anatomy and surgical procedures is required., • Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet the application requirements is required. This includes strong analytical, problem-solving, and decision-making skills with the ability to be observant and to think creatively., • Demonstrated ability to design experiments and analyze data with appropriate quality and statistical methodologies., • Demonstrated ability to work independently as well as effectively be a strong team contributor and work cross-functionally to expedite the completion of critical project tasks, • Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner., • Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills., • Requires strong leadership skills, excellent written and verbal communication and presentation skills., • Working knowledge of FDA requirements as per 21 CFR 820, ISO 9001, ISO 13485:2003, and ISO 14971:2007., • Working knowledge of Good Documentation Practices (GDP), and Good Manufacturing Practices (cGMP), • Good understanding of statistical tools and validation/verification techniques., • Proficiency in the use of Microsoft Excel, Microsoft Word, and Microsoft PowerPoint is required., • Legal authorization to work in the United States is required. Preferred Qualifications • An advanced degree (MS or Ph.D.) is strongly preferred., • Hands-on experience in product development with Class II and Class III medical devices., • Experience developing test methods and protocols/reports for safety and efficacy testing of implant and instrument designs., • Experience with IDE and PMA submissions., • Six-Sigma green belt or black belt certification Cresilon is an equal-opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits • Competitive annual base salary range of $100,000 - $160,000, depending upon job level and qualifications, • Paid Vacation, Sick, & Holidays, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%, • Work/Life Employee Assistance Program, • Company Paid Life and Short-Term Disability Coverage, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . Description: The Senior Process Engineer or Process Engineer II will support and lead manufacturing process development and optimization for our medical device products. This position plays a key role in ensuring that all manufacturing processes meet quality, compliance, and performance standards. The engineer will work closely with cross-functional teams including Quality, R&D, Regulatory, and Production developing, optimizing, and scaling manufacturing processes to improve yield, throughput, quality, and efficiency. The Process Engineer will have a strong operational, quality, and technical background. This is often a hands-on role working closely with the production team to train operators to new processes, troubleshoot equipment challenges, and write and execute qualifications and validations. This is a full-time, on-site position, located in Brooklyn, New York. It is a multi-faceted role in a highly collaborative environment that will require creativity and focused execution in pursuit of maximizing production outputs and creating robust manufacturing processes. Responsibilities: · Design, develop, and optimize manufacturing processes for new and existing medical devices. · Lead process development for new product introductions (NPI), from concept through validation and launch. · Develop and refine manufacturing processes to reduce variation, increase yield, improve cycle times, and reduce cost. · Evaluate and implement automation technologies to improve process consistency and throughput. · Interface with external vendors and suppliers to specify new equipment, product or process requirements, or troubleshoot product issues. · Analyze production data to identify trends, root causes, and opportunities for efficiency. · Maintain and update validation documentation as part of lifecycle management. · Ensure processes comply with applicable regulatory requirements and internal quality standards. · Lead root cause investigations (CAPA, NCRs, SCARs) and implement corrective and preventive actions. · Develop process documentation including standard operating procedures (SOPs), work instructions, pFMEAs, and equipment qualifications. · Partner with R&D during design transfer to ensure design for manufacturability (DFM) and seamless product integration. · Collaborate with Quality and Regulatory teams to support audits, inspections, and compliance initiatives. · Provide technical leadership and mentorship to junior engineers and technicians (for Senior level). · Monitor and analyze key process indicators (KPIs), quality metrics, and manufacturing data · Specify, procure, and validate manufacturing equipment and tooling. · Author and execute process validation protocols (IQ/OQ/PQ) in accordance with FDA and ISO 13485 standards. · Train manufacturing personnel on new or revised processes and equipment. · Provide ongoing floor support for manufacturing operations, helping to resolve technical issues in real time. · Other duties may be assigned as deemed necessary by management Requirements · Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related field. · Process Engineer II: 5+ years of experience in a regulated manufacturing environment with 3+ years process development, design, and process implementation required. · Senior Process Engineer: 10+ years of experience in a regulated manufacturing environment with at least 5 years hands-on experience in process development, design, and process implementation required, preferably in medical device, pharmaceutical, or biotech manufacturing. · Understanding of FDA 21 CFR Part 820, ISO 13485, and GMP requirements. · Proven experience with process validation (IQ/OQ/PQ), root cause analysis, and CAPA. · Proven experience in process design, optimization, and troubleshooting. · Experience implementing process and quality improvements into manufacturing or CMO · Strong analytical and problem-solving skills. · Ability to multitask and prioritize work, while remaining detail-oriented. · Demonstrated experience training technical personnel. · Familiarity with data analysis tools and manufacturing software. · Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. · Experience with Lean Manufacturing, Six Sigma, or similar methodologies. · Hands-on experience with manufacturing processes such as formulation, fill and finish, packaging, and CIP. · Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner. · Demonstrated experience managing third-party vendors and service providers. · Demonstrated ability to work independently as well as be a strong team contributor. · Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks. · Excellent verbal and written communication skills required. · Ability to become gowning qualified to work in a cleanroom environment. · Ability to speak, listen, and understand verbal and written communication in English. · Ability to lift 30 pounds of force occasionally and to lift, carry, push, pull, or otherwise move objects. · Strong computer skills, with proficiency in the use of Microsoft Excel, Microsoft Word, Microsoft PowerPoint. · Legal authorization to work in the United States. Preferred Qualifications: · Master’s degree in Engineering or related field. · Experience in medical device or pharmaceutical · 3+ years of relevant cGMP manufacturing experience. · Experience in cleanroom operations, including aseptic processing. · Experience with CMOs. · Significant experience with CAD software · Experience in supporting regulatory inspections and audit readiness. · Six Sigma certification (Green or Black Belt) or Lean Manufacturing experience. · Mechanical/Electrical knowledge with the ability to troubleshoot equipment · Strong leadership skills with the ability to influence and motivate a cross-functional team · Organizational and time management skills with the ability to prioritize a variety of tasks/projects. · Demonstrated understanding of aseptic processing and microbial control concepts. Benefits Competitive annual base salary range of $90,000 - $150,000, depending upon job level and qualifications. · Paid Vacation, Sick, & Holidays · Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage · Company Paid Life and Short-Term Disability Coverage · Work/Life Employee Assistance Program · 401(k) & Roth Retirement Savings Plan with company match up to 5% · Monthly MetroCard Reimbursement Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Job DescriptionSalary: $165,000-$185,000 Mamas Creations, Inc. (NASDAQ: MAMA) is a leading marketer and manufacturer of fresh deli prepared foods, found in over 8,500 grocery, mass, club and convenience stores nationally. The Companys broad product portfolio, born as MamaMancinis, from a rich history in Italian foods, now consists of a variety of high quality, fresh, clean and easy to prepare foods to address the needs of both our consumers and retailers. Our vision is to become a one-stop-shop deli solutions platform, leveraging vertical integration and a diverse family of brands to offer a wide array of prepared foods to meet the changing demands of the modern consumer. For more information, please visit . We have an excellent opportunity for a highly skilled and experienced leader to serve as the Senior Director, Plant Operations of our East Rutherford facility. You will be the senior site leader responsible for the overall performance, safety, Grandma Quality, controls, culture, and financial results of the manufacturing facility. This role serves as the plants general manager, accountable for translating enterprise strategy into consistent, disciplined execution with excellence at the site level. The Senior Director leads through people, systems, and standards, ensuring production, FSQA, maintenance, warehousing, and workforce leadership operate in alignment with Grandma Quality. This role balances results with responsibility, honoring Mamas heritage while building scalable, sustainable operations. Key Responsibilities • Own end-to-end plant performance, including safety, food safety, quality, service, cost, labor efficiency, and employee engagement., • Own overall plant efficiency and throughput performance, ensuring production capacity, labor models, and operating practices support enterprise targets., • Drive improvement in throughput, yield, and line performance by setting expectations, removing barriers, and holding leaders accountable for results., • Serve as the strategic leader for the site, translating enterprise priorities into clear site-level strategies, initiatives, and execution plans., • Partner with the Senior Manager, Production Operations to ensure production schedules and execution plans support optimal efficiency and service outcomes., • Own the plant operating budget, including labor, overtime, supplies, and controllable costs; ensure performance aligns with financial targets., • Balance cost discipline with Mamas commitment to Grandma Quality, safety, and employee well-being., • Use KPIs and financial data to evaluate performance, prioritize investments, and guide decision-making., • Partner with OpEx/CI to identify and sponsor continuous improvement initiatives that deliver measurable, sustainable gains in efficiency, throughput, and cost performance., • Ensure efficiency gains and cost improvements are sustainable and embedded into standard work and leadership routines., • Lead, coach, and hold accountable all direct reports, site functional leaders, and the downline., • Serve as the primary owner of plant culture, reinforcing values-based leadership, respectful supervision, and consistent accountability., • Ensure site execution aligns with enterprise standards of excellence and Grandma Quality while addressing location-specific risks and opportunities., • Partner with FSQA leadership to maintain strong food safety culture, regulatory compliance, and audit readiness., • Own site-level labor strategy, workforce planning, and performance management in partnership with People Operations., • Drive operational discipline through KPIs, operating practices, and structured problem-solving., • Partner with Reliability & Asset Management to support uptime, preventive maintenance execution, and capital improvements., • Support capital projects, expansions, and equipment installations at the site level., • Participate in operational diligence and integration activities related to acquisitions or expansions impacting the facility., • Serve as the primary escalation point for site risks, performance gaps, and employee relations matters., • Build strong cross-functional relationships that nurture trust, accountability, and pride in workmanship., • Collaborate closely with Senior Directors and plant leaders at other facilities to share best practices, standardize where appropriate, and drive enterprise-wide operational improvement., • Participate in cross-facility working groups, initiatives, and problem-solving efforts to strengthen consistency, performance, and scalability across the enterprise., • Champion collaboration between facilities while respecting site-specific strengths, constraints, and heritage., • Other related tasks, as necessary to drive results and support the business. Qualifications • Bachelors degree in Operations Management, Engineering, Business, or related field; or equivalent experience., • 15+ years of progressive leadership experience in manufacturing operations, preferably in food manufacturing or regulated environments., • 10+ years of experience leading multi-shift operations and managing leaders (managers/supervisors)., • Demonstrated experience owning site KPIs, budgets, labor planning, and operational performance improvement., • Expert usage of ERP systems. NetSuite preferred., • Strong working knowledge of food safety/regulatory environments (USDA/FDA), HACCP, GMPs, and audit readiness expectations., • Proven ability to lead through change while maintaining operational stability and culture., • Strong communication, planning, and cross-functional leadership skills., • Lean/Six Sigma knowledge/certification, preferred., • Bilingual (English/Spanish) highly preferred. Essential Physical Requirements • Ability to regularly walk, stand, and move throughout the manufacturing facility., • Ability to navigate stairs, catwalks, and uneven surfaces safely., • Ability to visually and audibly observe operations and employee practices., • Ability to wear required PPE (hair/beard nets, safety shoes, gloves, safety glasses, hearing protection)., • Ability to work in varying environmental conditions (heat, cold, noise, humidity)., • Ability to sit for extended periods while performing administrative work., • Ability to travel locally as required., • Ability to communicate clearly and effectively. We offer a comprehensive compensation package that includes a base salary (to $185k,) plus bonus eligibility, paid time off, holiday pay, medical, dental, vision, and life insurances, FSA, EAP, and 401(k.)

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: The Senior Statistical Programmer will contribute expert programming skills to deliver accurate, regulatory-compliant clinical data outputs for Compass Pathways development programs. The role requires strong technical proficiency, collaboration across teams, and adaptability to support complex clinical trial requirements. Location: Hybrid in our NYC Office or remote in the East Coast. Reports to: Associate Director, Statistics and Data Management. Duration: 9-month contract. Roles and Responsibilities (Include but are not limited to): • Leading and coordinating the programming activities within agreed timelines, • Managing the reporting of studies internally and externally, • Programming outputs as stated in the analysis plan, • Working closely with study team members, mainly with the study statistician, • Reviewing of the Statistical Analysis Plan (SAP) and shells, • Create and review SDTM and ADaM study specifications, • Ensure programs, datasets, outputs are appropriate for regulatory submission, • Perform simulations and data modelling, • Perform Interim analyses, • Extensive years experience in statistical programming, • CDISC expertise, • Proficient in programming including performing statistical analyses and creating macros in SAS, preferably R, • Programming/reporting expertise across all phases of clinical development (efficacy/safety/PK), including ISS/ISE reporting, • Experience in performing quality control (QC) checks, • Extensive knowledge in regulatory submission process, • Good understanding of ICH guidelines and regulations such as 21 CFR Part 11, • Experience supporting NDA submissions e.g., FDA, EMA, MHRA and addressing regulatory questions, • Ability to solve challenging problems and provide recommendations to mitigate risk, • Good communication skills - both written and verbal Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job DescriptionAs Senior Counsel, Advertising and Promotion, you'll be responsible for reviewing advertising, promotional, and other consumer-facing materials, ensuring they are compliant with FTC and FDA regulations and guidelines, and also manage a junior advertising and promotion attorney. You’ll partner closely with our Growth and Marketing teams to counsel on marketing content across the full spectrum of platforms, including websites, social media, podcasts, billboards, and TV. You have a strong knowledge of FDA and FTC advertising regulations and cases, and particularly with respect to prescription drugs and health products. You're smart, collaborative, and comfortable working in a dynamic environment while handling several projects at the same time. What You'll Do: • Serve as an internal subject matter expert on FTC and FDA advertising and promotion issues as they pertain to health products, and provide guidance to cross-functional teams to maintain compliance with FTC and FDA laws and regulations., • Sit on Ro’s collaborative medical-legal-marketing review process and review the creative assets for regulatory compliance. This content includes: Facebook and Google ads, website pages, national TV spots, podcast reads, billboards, contests and sweepstakes, and more., • Collaborate with cross-functional teams to support new strategic initiatives and advertising campaigns., • Stay abreast of changes in FDA and FTC regulations and industry trends in advertising, and monitor enforcement actions and relevant litigation., • Maintain company-wide guidelines and conduct trainings on advertising and promotion., • Provide guidance and oversight to an advertising and promotion attorney.What You'll Bring:, • Juris Doctor (JD) from an accredited law school., • Active member in good standing of a state bar association., • 5-8 years of experience practicing FDA and FTC law, and extensive expertise in the area of advertising and promotion of FDA-regulated products., • Exceptional analytical, research, and writing skills., • Strong communication and interpersonal skills, with the ability to build relationships across all levels of the organization., • Business-oriented mindset with the ability to translate legal advice into practical solutions., • Adaptable and able to thrive in a fast-paced, dynamic environment., • Self-starter with the ability to manage multiple projects simultaneously and meet deadlines., • Passion for the telehealth industry and a desire to make a meaningful impact.We've Got You Covered:, • Full medical, dental, and vision insurance + OneMedical membership, • Healthcare and Dependent Care FSA, • 401(k) with company match, • Flexible PTO, • Wellbeing + Learning & Growth reimbursements, • Paid parental leave + Fertility benefits, • Pet insurance, • Student loan refinancing, • Virtual resources for mindfulness, counseling, and fitnessWe welcome qualified candidates of all races, creeds, genders, and sexuality to apply. The target base salary for this position ranges from $215,500 - $264,000, in addition to a competitive equity and benefits package (as applicable). When determining compensation, we analyze and carefully consider several factors, including location, job-related knowledge, skills and experience. These considerations may cause your compensation to vary.

Job Description About Company: Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally. Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge. Job Description: RBA is looking for a psychiatrist who will serve as a Principal Investigator to join their team on a PT basis, M-F. The PI ensures adherence to protocol requirements, protecting the rights and welfare of study subjects, assuring the integrity of data generated at the site. In executing these position responsibilities, the Investigator is guided by and promotes the adherence to FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies. The ideal candidate will be a Family Medicine or Internal Medicine Physician. Responsibilities: Employee Mentoring Responsibilities • Work with Site Director, Study Coordinator, and Recruitment Manager to develop effective programs for study enrollment., • Work with Site Director to ensure that all staff are adequately trained and adhere to Standard Operating Procedure and working guidelines while performing study procedures on assigned studies., • Work with the Site Director to ensure the site has an adequate number of qualified staff, adequate facilities, and that the PI has adequate time to conduct the study., • Maintain a current, up to date curriculum vitae., • Maintain current licensure to practice., • Oversee all trial-related medical decisions or ensure that a qualified sub-investigator is available to do so., • Assess subject compliance with the test article and follow-up visits., • Assess subject's response to therapy., • Evaluate for adverse experiences per protocol guidelines., • Assist with rating scales., • Provide new information about the study or test article(s)., • Document deviations from the approved protocol., • Document and explain premature unblinding of the investigational product(s)., • Thoroughly familiar with the use of the investigational product(s)., • Education and experience, • M.D, D.O. required., • Requirements, • Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner., • Knowledgeable in medical terminology to communicate with physician office and laboratory staff., • Skilled in working with potential sponsors to place research with the site., • Work effectively with a staff of clinical professionals and creates a productive, satisfying work environment., • Demonstrate the ability to initiate activity as required and making appropriate decisions within the constraints of study protocols and, regulatory requirements., • Able to initiate or modify behavior to achieve desired outcomes despite environmental factors, priorities, or problems that might not be well defined or that are subject to change., • Experienced negotiation skills, • Formal presentation skills, • Excellent persuasive/selling skills., • Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines., • Excellent communication skills (interpersonal, written, verbal), • Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)