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Job Description We are Licensed Customs House Brokers looking for a highly motivated, customer service oriented data entry clerk. The hours are from 8:30 to 5:00. Import Entry Specialist - TCRS4556 HIGH LEVEL OVERVIEW The Import Entry Specialist is responsible for the timely and accurate filing of customs entries ensuring compliance with CBP and other government regulations. This is an on-site position based in Englewood Cliffs, NJ. EXPECTATIONS • Prepare, review, & process import entry documentation for air/ocean shipments and border crossings, • Work with CBP and other government agencies to resolve any compliance issues, holds, or queries, • Work with internal and external partners to provide timely clearance updates, • Maintain and manage client product database with HTS classification, • Stay current with changes to regulations and understand the impact to import entry processes, • Knowledge of U.S. Customs regulations; HTS Classification, COO, Valuation, • 3 years’ Customs Brokerage experience preferred, • Strong attention to detail, accuracy in data entry, and time-management skills, • Organizational skills and the ability to multitask in a fast-paced environment, • Understanding of FDA, DOT, and LACEY import regulations, • Knowledge of trade automation tools; CargoWise, ACE, etc., • Experience with import entry software, ideally Decartes/NetCHB, • Experience in Microsoft applications- Excel, Word, PowerPoint, OutlookCompany DescriptionLicensed Customs House BrokerLicensed Customs House Broker

Job DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech®, it’s about more than just a job—it’s about your career and your future. Your Role We are hiring a highly experienced Quality Director to join our team. The Director of Quality provides enterprise‑level leadership for quality governance, compliance oversight, and risk management across clinical development and research activities. This role is accountable for ensuring that clinical programs, laboratory operations, and external partners operate in alignment with global regulatory expectations and internal quality standards. As a senior leader, the Director of Quality partners closely with executive and functional leadership to embed quality by design, maintain inspection readiness, and support company-wide development programs. • Lead and execute the organization’s clinical and research quality strategy, ensuring alignment with GCP, GLP, internal standards, and global regulatory requirements., • Serve as the senior authority for quality governance, compliance oversight, and inspection readiness across development programs., • Establish, maintain, and continuously improve the Quality Management System, including SOP governance, training, deviation management, and CAPA processes., • Design and oversee risk‑based audit programs and provide quality oversight of CROs, laboratories, and other external partners., • Ensure regulatory inspection readiness through strong documentation practices, data integrity controls, and TMF oversight., • Partner cross‑functionally to integrate quality into clinical development plans, protocols, and operational execution., • Lead quality risk assessments, track key quality metrics, and communicate risks and trends to executive leadership., • Build, mentor, and lead a high‑performing quality organization while fostering a culture of integrity and continuous improvement. Requirements • Advanced degree in a related technical field., • 10–25 years of progressive experience in quality leadership within the pharmaceutical or biotechnology industry., • Deep expertise in GCP and GLP regulations supporting clinical development and research., • Demonstrated success leading quality systems, audit programs, and inspection readiness initiatives., • Strong understanding of global regulatory frameworks (FDA, EMA, ICH, and related authorities)., • Proven ability to influence senior stakeholders and operate effectively in a matrixed environment., • Exposure to complex or specialized therapeutic areas., • Background in quality support for strategic partnerships, licensing transactions, or acquisitions., • Prior experience building or scaling quality organizations in growing or evolving companies., • Must be authorized to work in the U.S., • No C2C at this time. BenefitsDepending on the candidate’s experience, qualifications, and evolving business needs, this role may be structured as either a temporary or full-time position. Temporary roles include our medical and sick time benefits. Full-time positions are fully benefited in accordance with company offerings. Adhering to the requirements of New York's law on salary transparency, the salary bracket for this role is set between $125,000 - $155,000 annually. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience. Equal Opportunity Employment Statement PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law. #LI-RT1

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionABOUT PROJECT HEALTHY MINDS Project Healthy Minds is a mental health tech non-profit startup. We are pioneering a first-of-its-kind model: applying technology to address one of the biggest social issues of our time: the growing mental health crisis. We believe in a simple but profound idea: that it should be as easy to find mental health services as it is to book a flight or a restaurant reservation. That's why we're building the world’s first digital marketplace for finding mental health services that are right for you. To do that, we work with some of the most inspiring and influential leaders in America - business titans, tech entrepreneurs, clinicians and scientists, musicians, artists, athletes, media stars, policymakers, and more - because we believe that the world's most complex challenges require interdisciplinary teams and solutions. We are backed by a powerhouse of industry-leading Board of Directors and Advisory Council Members who are passionate, hands-on, and dive into the important work with us. Learn more at projecthealthyminds.com and @projecthealthyminds on social. ABOUT THE ROLE WHAT WE’RE LOOKING FOR:We’re hiring a Director of Live Programming who will oversee the production, programming, and overall attendee experience of the Project Healthy Minds World Mental Health Day festival and other brand-forward experiences. This leader should have four superpowers: • An extraordinary level of creativity and experience conceptualizing and producing outside-the-box, elevated events.• The production chops to make a Coachella production manager blush – someone who intuitively understands production specs and labor needs, has a deep network of vendor relationships and knows how to negotiate and manage vendors, knows all of the different shapes of venue deals and just as importantly, knows how to work with venues, and has the leadership qualities to lead a multi-stakeholder process for signature events and ensure the production of our events is world-class.• You live for producing one-of-a-kind, consumer-oriented, brand-forward experiences – from pop-ups to festivals and everything in between. You’d say you could have produced Spotify House at Ole Red in your sleep. • Exquisite taste and editorial brilliance to curate the right topics, speakers, and participants to ensure Project Healthy Minds events are some of the most intellectually interesting events around. This role will report into the VP of Development, will work very closely with the Founder & CEO, and will serve as a leader working cross-functionally with other members of the Development and Creative teams to conceive and execute groundbreaking events. HOW YOU’LL CONTRIBUTE:• Set the strategic vision and roadmap for the Project Healthy Minds World Mental Health Day Festival – the world’s first and largest – and other brand-forward experiences. • Lead the strategy for the Project Healthy Minds World Mental Health Day Festival – setting the programming, editorial, and talent vision, shaping the creative direction (with the Head of Creative), creating the production and staffing plans, etc. • Drive the execution of all festival production elements end-to-end in a hands-on manner – providing strong day-to-day leadership to all internal stakeholders, external vendors, and venue partners. • Lead all vendor and venue relations – from sourcing to negotiation to management to reporting.• Quarterback the process for securing talent for the festival and other brand-forward experiences – working in close partnership with the CEO, the VP of Development, Board of Directors, internal staff, and other key VIP partners/friends to Project Healthy Minds.• Create detailed end-to-end planning timelines for events and run the process to ensure best-in-class execution across the team.• Own the P&L for all events.• Oversee the creation of all event materials (e.g. digital experiences, printed materials at the event, etc.) – working in close partnership with the Creative and Development teams.• Ensure a world-class guest experience, thoughtfully considering the end-to-end user journey across every Project Healthy Minds touchpoint (pre-event, day-of, post-event).• Partner with the rest of the development staff to create thoughtfully curated invite lists and initiation strategies.• Manage partners and stakeholders.• Provide robust reporting to various stakeholders throughout the event planning and recap cycle. ABOUT YOU OUR IDEAL CANDIDATE IS:• A true event production pro – you have a proven track record with all aspects of events – from conceptualizing the programming structure and flow to setting timelines and driving planning processes to coordinating all production aspects (audio, video, labor, staging, catering, etc.) to leading the negotiation and management of labor/production needs to sourcing and managing vendors to creating detailed run-of-shows and so much more.• Detail-oriented and the most organized person in the room – you love developing effective systems. You are a meticulous planner and can ensure that all the moving parts of an event are clear and categorized. You keep the trains on the track and ensure all stakeholders meet deadlines.• Creative and seeking to establish a new standard for experiential – you have your pulse on what’s happening across the events landscape: fashion events, editorially-driven events produced by major media companies, music festivals, elevated VIP corporate client events, etc. You want to create cutting-edge experiences that everyone else can’t stop talking about. You have extensive experience working on events at media companies and/or on large-scale cultural events (think SXSW, Atlantic Festival, New York Festival, WSJ Future of Everything Festival, NYTimes Live, Coachella, Burning Man, or Cannes Film Festival).• A leader who enjoys building something new – you thrive in a fast-paced environment and identify as a multitasker that can perform under pressure. You enjoy leading cross-functional teams and being the leader that everyone looks to for vision, decisions, and timely feedback. You respond skillfully to rapidly changing priorities and are excited by the prospect of every day being different with new problems to solve. You are willing to travel for this role if needed.• A strong communicator – you have exceptional oral and written communication skills with an ability to engage and inspire a wide range of audiences and a diverse team of stakeholders. • Experienced – Bachelor’s degree and 15-20+ years of experience running events with proven success, ideally in the nonprofit space. WHAT WE OFFER

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: Our Senior Director, HCP Marketing will lead the development and execution of comprehensive healthcare professional engagement strategies to drive awareness, education, and adoption of COMP360. This role will be responsible for creating targeted HCP marketing campaigns, building strategic relationships with key opinion leaders and prescriber segments, and developing evidence-based educational initiatives that support launch readiness and commercial success. Location: Hybrid in our New York City office or remote on the east coast in the United States. Reports to: Chief Commercial Officer. Roles and responsibilities (Include but are not limited to): HCP and Consumer Strategy and Targeting • Develop and execute targeted HCP and consumer marketing strategies aligned with brand positioning and commercial objectives, • Lead HCP segmentation, targeting, and prioritization efforts in collaboration with Sales and Market Access teams, • Design engagement pathways optimized for different HCP personas including psychiatrists, primary care physicians, and institutional prescribers, • Design engagement pathways optimized for consumers and caregivers, • Create compelling, compliant educational content and promotional materials for HCP audiences that translate clinical data into practical insights, • Collaborate with Medical Affairs on KOL engagement strategy, advisory boards, and scientific communications to build clinical credibility, • Develop congress strategies, medical education programs, and peer-to-peer learning initiatives, • Lead omnichannel marketing strategy across digital, in-person, and virtual touchpoints to deliver personalized HCP experiences, • Drive digital marketing initiatives including HCP portals, email campaigns, social media engagement, and webinars, • Partner with Sales on field enablement, ensuring representatives have compelling messaging and materials for HCP interactions, • Build and lead a full cross‑functional marketing team, overseeing PME, Consumer, and Digital Marketing to drive cohesive strategy and execution, • Collaborate closely with Market Access to align HCP messaging with payer and reimbursement strategies, • Partner with Site of Care Marketing to ensure coordinated patient-provider messaging and journey optimization, • Work with Regulatory and Legal to ensure all HCP-facing materials meet compliance requirements, • 10+ years pharma/biotech marketing experience with demonstrated expertise in HCP engagement; CNS/psychiatry experience strongly preferred. Launch experience an asset, • Proven track record developing and executing successful HCP marketing strategies for specialty therapeutics or novel mechanism launches, • Deep understanding of HCP prescribing behaviors, clinical decision-making, and healthcare professional networks, • Bachelor's degree in life sciences, marketing, or related field; advanced degree or MBA preferred, • Strong expertise in omnichannel marketing, digital engagement platforms, and medical marketing in regulated environments, • Excellent scientific acumen with ability to translate complex clinical data into compelling HCP messaging, • Experience collaborating with Medical Affairs, Sales, and Market Access in launch environments, • Outstanding communication, stakeholder management, and cross-functional influence capabilities Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$250,000—$330,000 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: 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 Description Job Title: Quality Improvement Compliance Monitor Grade: 28 Salary: $109,145 - $117,588 The Research Foundation for Mental Hygiene is seeking a qualified candidate to fill a full-time Quality Improvement Compliance Monitor position. Reporting to the QIE Director and part of the greater HRPP, the incumbent will conduct site initiation visits and post-approval monitoring reviews of human subject research projects to ensure compliance with federal regulations and guidelines and NYSPI policies. Reviews often focus on, but are not limited to, review of recruitment practices, potential participant screening, adherence to eligibility criteria and the protocol, informed consent procedures, participant safety, document storage, and confidentiality of data. Note: This is a hybrid role with 50% on-site requirement Duties and Responsibilities: • Conducting for-cause audits authorized by the IRB or institutional official., • Writing reports and communicating findings with investigators, compliance committees, and appropriate parties., • Conducting education and training throughout the monitoring process with the ability to recommend further training to the human research education committee., • Providing regulatory guidance to the NYSPI research community. Assisting with site or study-specific research self-assessments., • Bachelor's Degree, • Previous experience as a member of a research team (i.e., study coordinator/research assistant), • Thorough knowledge of state and federal codes (Revised Common Rule, FDA, etc.) regarding research., • Considerable knowledge of Good Clinical Practice (GCP), • Certification as a Clinical Research Associate (CCRA) or SOCRA Certified Clinical Research Professional (CCRP), • Advanced computer/technical skills, • Strong organizational skills To Apply: Submit an application through our website at . Please note only applications submitted through our website will be considered. The Mission of the Research Foundation for Mental Hygiene, Inc. (RFMH) is to promote the mental health of all New Yorkers, with a focus on providing hope and supporting recovery for adults with serious mental illness and children with serious emotional disturbances. Applicants with lived mental health experience are encouraged to apply. RFMH is deeply committed to supporting underserved individuals, organizations, and communities. To this end, RFMH is focused on implementing activities and initiatives to reduce disparities in access, quality, and treatment outcomes for underserved populations. A critical component of these efforts is ensuring that RFMH is a diverse and inclusive workplace where all employees' unique attributes and skills are valued and utilized to support the mission of the Agency. RFMH is an equal opportunity/affirmative action employer. The Research Foundation is a private not-for-profit corporation and is not an agency or instrumentality of the State of New York. Employees of the Research Foundation are not state employees, do not participate in any state retirement system, and do not receive state fringe benefits. Excellent Benefits Package. Affirmative Action/Equal Opportunity Employer - Disabled/Veteran, 41 CFR 60-741.5(a) and 41 CFR 60-300.5(a) compliant. Job Posted by ApplicantPro

Job Description Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. Today, we’re expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world. At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We’re dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress. Join us and be part of a company where your contributions make a real impact, because we know someone’s health is in our hands. Summary of role The Radiopharmaceutical Clinical Applications Associate Director will be responsible for leading the clinical application efforts regionally for our radiopharmaceutical products. This role involves building and maintaining relationships with Key Opinion Leaders (KOLs) and Healthcare Providers (HCPs), providing advanced clinical and technical expertise, and ensuring the optimal use of our products in the clinical setting. The position will also support field research initiatives, provide educational training, and ensure compliance with industry regulations and company policies. This is a remote position open to applicants authorized to work for any employer within the United States. The territory includes MA, NY City, CT, RI, NH, ME, VT. Responsibilities • Identify, develop, and engage in long-term relationships with Key Opinion Leaders (KOLs) and Healthcare Providers (HCPs) in the assigned territory, including Nuclear Medicine Physicians, Radiologists, Radiation Oncologists, Technologists, Safety Officers, Health Physicists, Nursing Staff, and Advanced Practice HCPs at imaging facilities and medical centers., • Provide training to imaging/treatment centers on handling, administration, and radiation safety of current products, including initial and re-training sessions., • Educate on-site preparation and infusion processes for products, including radiopharmaceutical licensing, supporting approved imaging/therapies, and clinical trials., • Educate the HCP community to ensure they have the proper knowledge and technical expertise to use Lantheus products safely and effectively., • Utilize clinical and technical expertise to institutional workflows, regional diagnostic imaging patterns, treatment guidelines, and therapeutic advances in oncology and molecular imaging. Gather insights into the needs and interests of healthcare providers and the medical needs of patients with a focus on Lantheus approved and investigational agents., • Maintain thorough and up-to-date knowledge of imaging techniques, clinical information, and product data in the diagnostic and therapeutic radiopharmaceutical field., • Respond appropriately and document accurate scientific data in response to unsolicited questions from customers about approved and investigational products., • Support Lantheus Field Research Initiatives, including Investigator Sponsored Trials (ISTs), the Image Library, and Clinical Trials aligned with the Lantheus pipeline., • Attend national congresses and meetings, providing medical and scientific booth support as requested, in compliance with industry regulations., • Fully understand and comply with all Lantheus SOPs, working procedures, and corporate requirements., • Minimum Bachelor’s Degree Required, • 4+ years Nuclear Medicine Technologist, Clinical Application Specialist, or similar/relevant experience., • 2+ years Clinical experience in oncology, urology, neurology or radiopharmaceuticals/medical imaging, • Exceptional communicator and presenter with proven oral and written communications skills., • Advanced understanding of current and emerging trends in the field of Nuclear Medicine, radiopharmaceuticals, and diagnostic imaging., • Proficient at translating and communicating approved scientific or clinical data into high quality medical information appropriate to the audiences engaged., • Demonstrated success working in a team environment, communicating clearly and effectively with management, peers, and all cross-functional teams., • Highly motivated to achieve optimal results with a demonstrated record of career growth and achievement., • Advanced Word, PowerPoint, and Excel skills The ideal candidate will embody Lantheus core values: • Let people be their best, • Respect one another and act as one, • Learn, adapt, and win, • Know someone’s health is in our hands Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until February 28, 2026. Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law. Lantheus is an E-Verify Employer. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at .

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 Manager, Clinical Quality is responsible for developing and implementing a risk-based GCP (Good Clinical Practice) audit program. This includes planning and conducting audits, coordinating the activities of independent QA auditors, and supporting regulatory inspection readiness activities and regulatory inspections by EMA, FDA and other competent authorities. The role contributes to quality risk management and continuous improvement across clinical trials and related processes. Location: Remote on the East Coast, USA or hybrid working in our NYC office. Reports to: Director, Clinical Quality. Responsibilities (include but are not limited to): • Provision of GCP QA advice and support to clinical project teams and cross-functional departments to help ensure compliance with applicable regulations and internal quality standards, • May act on behalf of the Director, Clinical QA, to provide leadership support and ensure continuity of QA oversight and decision-making, • Manage GCP audits of sites, documents, databases, vendors, or internal systems in compliance with GCP and Compass quality standards, • Coordinate activities of external auditors, during the preparation, conduct and reporting of GCP audits, • Support, and conduct when required, risk-based audits of clinical trial sites, both internally and those managed by CROs (Contract Research Organizations), vendors and internal systems ensuring adherence to GCP guidelines, protocols, and regulatory standards, • Support the preparation of comprehensive audit reports, identifying potential issues and recommending corrective actions for internal teams and collaborating with CROs to implement necessary changes, • Work closely with internal teams to ensure alignment with GCP expectations to address findings and action items from audits, • When required, lead investigations into significant quality issues, facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness, • Proactively assess compliance issues and risks; serve as the expert GCP consultant for issue management & issue escalation, • Support partner organizations as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, investigations, and CAPAs are initiated, addressed, and closed within target timeframes, • Support the management of GCP inspections within Compass and at vendors/partners of Compass studies and/or processes, as required, • Liaise with regulatory agencies (e.g., FDA, EMA) regarding GCP compliance matters, • Stay up-to-date on evolving GCP regulations and best practices in clinical trial audit methodology, • Participate in the development and implementation of training programs for clinical trial staff, both internal and at CRO partners, on GCP and regulatory compliance, • Degree in a life science field or a related clinical research area (preferred), • GCP QA professional with broad drug experience which spans all clinical phases (Phase I to IV), • Extensive experience in GCP auditing and clinical trial operations, • In-depth knowledge of GCP guidelines (ICH-GCP) and regulatory requirements for clinical trials, • Strong understanding of clinical trial design, conduct, and data management, • Excellent leadership, communication, and interpersonal skills, • Strong analytical and problem-solving skills, • Ability to work independently and as part of a team, • Excellent project management skills 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 Description Welcome! Ovid Therapeutics Inc. is a New York-based biopharmaceutical company dedicated to developing small molecule medicines for brain conditions and symptoms caused by excess neural excitability. Ovid is advancing a pipeline of novel targeted small molecule candidates that modulate the intrinsic and extrinsic factors involved in neuronal hyperexcitability causative of multiple neurological and neuropsychiatric disorders. It is with curiosity, courage, and tenacity that, together, we work for meaningful change in the lives of patients and their families. With this sense of purpose and urgency we challenge the conventional and embrace the wisdom and thought that comes from diverse backgrounds and perspectives. Importantly, we understand the commitment we make to our patients, our broad community and to each other is based on the humanity that we share. The Role On Our Team We are seeking an experienced Clinical Operations professional in New York City, Philadelphia, or Boston area for our trials spanning early to late-stage clinical development. Your role will be responsible for overseeing and managing all aspects of clinical operations for a high priority program. This individual possesses clinical operations expertise with a track record of success, working with peers and stakeholders working cross functionally with Clinical Development, Regulatory, Non Clinical and other internal functions to develop operationally feasible and clear protocol concepts and final protocols, and will independently oversee one or more clinical studies by establishing the operational strategy and securing excellence in execution through external partners to drive programs with multiple studies and indications through all phases of clinical trials (Phase I-III). This role will be a leader in the organization who knows how to manage a team internally, at our clinical sites and with our vendors. Reporting to the Sr Vice President, this is a highly visible and team-facing role. The role is a hybrid of office visits in NYC, working from home, and traveling to our sites and for business meetings. Key Responsibilities and Impact • Manage interactions with and between clinical monitors, biostatistics, medical writing, safety and other key stakeholders and effectively interact with scientists and managers within and outside Clinical Research Organization (CRO), vendors, and partners. Have strong outsourcing experience, • Provide program-level sponsor’s operational oversight of our strategic partners and other vendors to ensure the effective execution of the clinical studies on time, with high quality and within agreed budget, • Develop and lead the program-level operational strategy and planning on assigned programs in close collaboration with our strategic partners and other vendors, • May also be responsible for contributing to a clinical development plan within a program moving into a new or subdivision of a current indication, • Organize and lead study specific meetings, • Develop scientifically robust, operationally feasible and clear protocol concepts and protocols, robust, data monitoring plans, and other study documents, • Develop operational strategy along with CRO/vendors aligned with the program strategy and incorporating local and country-level input, • Lead and oversee the strategic planning, implementation and execution of clinical trials across key programs in accordance with project timelines, budget, and quality standards, • Develop and manage comprehensive program project plans, including but not limited to, study protocols, clinical trial budgets, timelines, enrollment and risk mitigation strategies, • Collaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs, Biostatistics, Translational Medicine and Program Leadership to ensure alignment on clinical trial objectives and milestones, • Provide operational expertise and strategic input into the development of Clinical Development Plans (CDP), supporting the overall clinical strategy for the program, • Serve as the point of contact for CROs and vendors, overseeing their performance and ensuring adherence to contractual agreements, timelines and quality standards, • Ensure compliance with regulatory requirements, ICH-GCP requirements, and company SOPs throughout all stages of clinical trial conduct, • Oversee the collection, analysis and interpretation of clinical trial data, working closely with Clinical Development, Biostatistics and Data Management teams to ensure data accuracy and integrity, • 10+ years of clinical research / project management experience preferably with both a sponsor company and CRO managing outsourced clinical trials within quality, timeline, and budget expectations., • Detailed understanding and experience in all aspects of clinical protocol development, implementation, regulatory submissions, and overall drug development, • Ability to establish operational plans and support the CRO/vendor in the execution of the plans., • Prior investigator site and/or monitoring experience is advantageous, • Deep knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the development of study designs is desirable., • Adaptability, flexibility, independence, and resourcefulness to roll-up-sleeves and multi-task so to thrive in a small company, fast-paced environment, • Marked proficiency in clinical and/or medical writing, • Broad experience in early-stage and late-stage development programs, • Demonstrated experience working with FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States, • Extensive knowledge of regulatory guidelines and experience with worldwide regulatory agencies in therapeutic product development; global experience highly preferred, • Outstanding presentation, written and oral skills are required. A clear communicator who can influence effectively both internally and externally, • Bring a history of great collaboration and teamwork with the ability to motivate and influence others; have a reputation for successful partnering with internal and external stakeholders, • Have the ability and the drive to succeed in a small biotech organization. Interest to grow in the function to advance new technologies in new therapies. Must be self-motivated, proactive, work well under pressure and deadlines, and thrive in a small “all hands-on deck” environment, • Solution-oriented thinker who possesses a “can do” attitude with a strong sense of urgency, • Create a balance of analytical and methodical problem solving with creative and flexible solutions Ovid operates in a hybrid-work model. Candidates applying must be willing and able to be in the NYC office in coordination with their manager's expectations, as well as department and business needs. The base salary range for this position is $200,00-270,000. The actual salary offered within the range is dependent on a variety of factors including, but not limited to, relevant experience, qualifications, skills, level offered, and performance expectations. Powered by JazzHR lJ9lJ1vhhf

Job DescriptionAbout CookUnity: Food has lost its soul to modern convenience. And with it, it has lost the power to nourish, inspire, and connect us. So in 2018, CookUnity was founded as the first-of-its-kind platform that connects the world with the source of truly great food: chefs. Today, CookUnity delivers 50 million meals a year from the industry's best chefs to homes all over the country. Fresh. Ready-to-eat. And crafted with the passion that nourishes body and soul. Unwilling to stop there, CookUnity is expanding beyond delivery to become an ever-innovating marketplace focused on our singular mission: empower Chefs to nourish the world. If that mission has you hungry in more ways than one, you've found the right job posting. The Role CookUnity is seeking an experienced and highly motivated Senior Manager, Food Safety to lead and scale food safety excellence across our NYC operations. This role is central to enabling CookUnity's rapid growth and marketplace expansion by building robust, data-driven food safety systems that protect customers, strengthen brand trust, and support operational innovation. Reporting into senior Quality & Food Safety leadership, this role partners closely with Operations, Culinary, Supply Chain, and Regulatory teams to embed preventive controls, regulatory readiness, and continuous improvement into daily execution. The ideal candidate is both strategic and hands-on—equally comfortable setting enterprise standards and working directly on the production floor. Responsibilities • Lead site-level food safety strategy for high-volume, ready-to-eat meal production, ensuring alignment with CookUnity's growth, retention, and marketplace objectives, • Serve as the primary food safety authority for regulatory agencies, third-party audits, and inspections; own inspection readiness, execution, and corrective action management, • Oversee preventive control programs and critical limits, including cold-chain management, sanitation systems, chemical controls, and cook-chill processes, • Analyze, trend, and interpret food safety and environmental monitoring data to proactively identify risk and drive continuous improvement, • Design, implement, and scale food safety programs, including internal and Chef audits, shelf-life validation, environmental monitoring, and risk assessments, • Partner with Operations and Culinary leaders to integrate food safety into production planning, new menu launches, and process innovation, • Lead food safety investigations, root cause analysis, and CAPA programs to prevent recurrence and strengthen systems, • Develop and deliver engaging training programs for GMPs, sanitation, allergen control, and safe food handling for employees and Chef partners, • Build and mentor high-performing food safety team members, fostering technical excellence and leadership capability, • Translate evolving federal, state, and local regulations into clear, practical standards that support speed, consistency, and compliance, • Champion a strong, proactive food safety culture across multiple shifts and teams in a fast-paced environmentQualifications, • Bachelor's degree in Food Science, Microbiology, Food Safety, or a related discipline; advanced degree preferred, • HACCP, PCQI, and/or Certified Food Safety Manager credentials, • 7+ years of progressive experience in food safety, quality, or regulatory leadership within ready-to-eat, fresh, or high-compliance food production environments, • Demonstrated success leading food safety programs at scale in complex, high-growth operations, • Strong working knowledge of FDA, USDA, and local regulatory requirements, preventive controls, and HACCP systems, • Proven ability to influence cross-functional leaders and drive change without direct authority, • Excellent communication, training, and stakeholder engagement skills, • Highly analytical, detail-oriented, and comfortable working with performance data and risk metrics 🌅 401k Plan 📈 We grow, you grow: Stock Options Plan granted on Day 1 🌟 Eligible for a bi-annual performance bonus ⛱ Unlimited PTO 🗓️ 5-year Sabbatical: After 5 years with CookUnity, you get a 4-week paid sabbatical 🐣 Paid Family Leave 🕯 Compassionate Leave: 3–5 days each time the need arises 🥘 Monthly CookUnity credits to enjoy our meals 🧘🏽️‍♀️ Wellness perks: nutritional coach access and fitness subsidies 👩🏾️‍🏫 Personalized Spanish coach 🌟 Opportunity to join a company that's redefining how we eat and how chefs work Compensation All final pay rates will be determined by candidates experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data.Pay Range for this position$140,000—$160,000 USD If you're interested in this role, please submit your application, and if we think you might be a fit, we'll get in touch with you. Thank you for your time! CookUnity is an Equal Opportunity Employer. We are dedicated to creating a community of inclusion and an environment free from discrimination or harassment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, citizenship status, protected veteran status, genetic information, or physical or mental disability. A quick note for all candidates We've recently seen an increase in recruitment scams across the industry, and we want to make sure you (and your data) stay safe while applying to CookUnity. We also want you to know that we take this seriously — sometimes, as part of our process, we may ask for a brief "proof of humanity" to confirm that we're connecting with a real person, not an impersonator. Here are a few tips to help you protect yourself and know what to expect from us: • Apply only through our official channels. All open roles are listed on our official careers page: careers.cookunity.com, • Our recruiters are real people — and easy to verify. You can always find them on LinkedIn with verified profiles. If you're unsure, feel free to reach out to us on our official LinkedIn Company Page., • We only communicate through official CookUnity channels. That means emails ending in @cookunity.com and interviews held through official company platforms (Google Meet or Zoom) — never WhatsApp, Telegram, or SMS.

Job DescriptionABOUT PROJECT HEALTHY MINDS Project Healthy Minds is a mental health tech non-profit startup. We are pioneering a first-of-its-kind model: applying technology to address one of the biggest social issues of our time: the growing mental health crisis. We believe in a simple but profound idea: that it should be as easy to find mental health services as it is to book a flight or a restaurant reservation. That's why we're building the world’s first digital marketplace for finding mental health services that are right for you. To do that, we work with some of the most inspiring and influential leaders in America - business titans, tech entrepreneurs, clinicians and scientists, musicians, artists, athletes, media stars, policymakers, and more - because we believe that the world's most complex challenges require interdisciplinary teams and solutions. We are backed by a powerhouse of industry-leading Board of Directors and Advisory Council Members who are passionate, hands-on, and dive into the important work with us. Learn more at projecthealthyminds.com and @projecthealthyminds on social. ABOUT THE ROLE WHAT WE’RE LOOKING FOR: The Manager, Fundraising & Special Events is a mission-driven, detail-obsessed, highly organized events professional who will support and help execute Project Healthy Minds’ ambitious slate of fundraising and cultivation events. Reporting to the Senior Strategic Events, Fundraising & Production Lead, this role plays a critical part in producing elevated, culturally resonant experiences—from large-scale signature fundraisers to intimate VIP salon dinners, corporate partner activations, and national parlor gatherings. Project Healthy Minds' events are a critical engine for fundraising, storytelling, and community building. This role ensures that every experience reflects the excellence, creativity, and care our mission deserves. The Manager, Fundraising & Special Events will be an essential partner in scaling a national events program that sparks deeper connection, inspires generosity, and brings the movement for mental health to life. This person thrives in a fast-paced, creative environment and is excited by the challenge of helping a growing nonprofit build a world-class events program. They bring a strong production foundation, impeccable project management, and a collaborative mindset. The ideal candidate is equal parts logistics pro, relationship builder, and brand ambassador. HOW YOU’LL CONTRIBUTE: Event Planning & Production Support• Work closely with the Senior Strategic Events, Fundraising & Production Lead to execute the full Project Healthy Minds events calendar, including signature fundraisers, salon & parlor events, corporate activations, and wrap-around programming events.• Support end-to-end production, including timelines, run-of-show drafts, vendor coordination, venue walkthroughs, deliveries, load-in/out schedules, staffing plans, and onsite event management.• Manage logistics for smaller events independently, serving as the day-to-day lead under the Senior Strategic Events, Fundraising & Production Lead's strategic direction.• Assist with event design & vendor sourcing.• Maintain strong relationships with event production companies, A/V teams, rental partners, caterers, printers, photographers, and transportation/lodging partners.• Track vendor deliverables, deadlines, and invoices; support budget reconciliation. Guest Experience & Donor Stewardship• Ensure a seamless guest experience across invitation, registration, arrival, program, and post-event follow-up.• Support thoughtful stewardship practices, including personalized follow-up, recognition touchpoints, and donor engagement tracking. Project Management & Internal Coordination• Manage guest lists, RSVP tracking, seating charts, and check-in tools in close collaboration with the Revenue team.• Support talent, speaker, and guest communications, including event prep materials, schedules, and hospitality.• Support creation and maintenance of detailed event project plans, production schedules, and internal workstreams.• Support the creation of briefing documents, scripts, call sheets, run-of-shows, floor plans, and internal memos. Fundraising & Development Support• Partner with the Revenue team to support sponsorship deliverables and activation needs.• Assist with solicitation materials, sponsor fulfillment, and post-event stewardship touchpoints.• Help prepare reporting, recaps, and metrics for internal and external audiences.• Support prospect research related to events and cultivation efforts, including identifying, qualifying, and briefing potential donors, sponsors, and hosts in partnership with the Development Operations teams.• Assist with building and maintaining prospect pipelines tied to events, including tracking engagement history, relationships, and next steps in the CRM.• Prepare concise donor and prospect briefing materials (profiles, talking points, giving context) to support senior leadership, board members, and hosts • Support pre and post-event fundraising strategy by helping identify follow-up opportunities, stewardship priorities, and cultivation pathways stemming from event engagement. ABOUT YOU OUR IDEAL CANDIDATE:• 5–7 years of experience in special events, production, nonprofit fundraising events, or related fields.• Strong project management skills -- you love a timeline, a tracker, and a well-organized Google Drive.• Comfort working with vendors, production teams, and high-profile stakeholders.• A proactive, “no job too big or too small” attitude; willingness to dive in at every level of execution.• Excellent communication skills, professionalism, and discretion when working with VIP guests, donors, and partners.• Strong aesthetic sensibility and interest in design, culture, talent, and storytelling.• Experience with CRM, project management, guest list platforms, or event management tools is a plus (e.g., Salesforce, Monday.com, Zkipster).• Ability to thrive in a fast-moving environment with shifting priorities.• A passion for mental health and the mission of Project Healthy Minds. WHAT WE OFFER

Job Description A cuttingedge biotechnology company is seeking a Senior Director, Regulatory Affairs to lead global regulatory strategy across a portfolio of innovative, highimpact programs. This team is composed of world-class scientists and innovators who are leading the charge on integrating advanced imaging and AI technologies to revolutionize drug discovery The Senior Director, Regulatory Affairs will oversee the design and execution of regulatory strategies from early development through registration, ensuring alignment with U.S. and international requirements. The ideal candidate will bring deep expertise in global regulatory pathways, exceptional leadership in crossfunctional settings, and the ability to provide strategic guidance across R&D, Clinical, and Quality functions while serving as a key liaison with regulatory authorities. Responsibilities: • Develop and execute comprehensive regulatory strategies supporting development, approval, and commercialization., • Ensure alignment of regulatory plans with corporate objectives and clinical development goals., • Maintain deep awareness of evolving U.S. and global regulations, guidelines, and industry standards., • Ensure all company activities and programs adhere to applicable regulatory requirements., • Oversee the preparation, review, and delivery of regulatory submissions such as INDs, NDAs, BLAs, and MAAs., • Ensure submission packages are scientifically sound, strategically positioned, and delivered on time., • Partner closely with Clinical Development, Research, Quality, CMC, and other key stakeholders to integrate regulatory considerations into development programs., • Provide clear, proactive regulatory guidance across program teams., • Support regulatory aspects of quality systems, including adherence to GCP, GLP, and other relevant standards., • Ensure inspection readiness and alignment with regulatory expectations., • Identify regulatory risks and develop mitigation strategies across programs and functions., • Anticipate potential regulatory challenges and proactively guide teams toward solutions. Qualifications • Postgraduate degree with 12+ years of regulatory affairs experience, or bachelor's degree with 15+ years of relevant experience., • Prior experience as a people manager is a requirement, • Extensive knowledge of FDA and global regulatory requirements and guidelines., • Proven experience supporting regulatory strategy across all stages of the product lifecycle, • Oncology experience is a plus, • Proven leadership experience in developing and executing regulatory strategies., • Strong communication, negotiation, and crossfunctional partnership skills., • Analytical, detailoriented, and solutionsfocused, with the ability to operate in a fastpaced environment., • Demonstrated adaptability and readiness to lead in a highgrowth, innovationdriven setting. Company DescriptionA top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints. Job Responsibilities: -\tConducting Post Market Activities and Post Market Surveillance -\tManaging Customer and Product Complaint Investigation programs Education and Experience: -\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry -\tBachelor's degree -\tComputer proficiencyA top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.\r\nJob Responsibilities:\r\n•\tConducting Post Market Activities and Post Market Surveillance\r\n•\tManaging Customer and Product Complaint Investigation programs\r\nEducation and Experience:\r\n•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry\r\n•\tBachelor's degree\r\n•\tComputer proficiency

Job Description About Cleerly We're Cleerly – a healthcare company that's revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world's leading cardiologists and are a growing team of world-class engineering, operations, medical affairs, marketing, and sales leaders. We raised $223M in Series C funding in 2022 which has enabled rapid growth and continued support of our mission. In December 2024 we received an additional $106M in a Series C extension funding. Most of our teams work remotely and have access to our offices in Denver, Colorado, New, York, New York, Dallas, Texas, and Lisbon, Portugal with some roles requiring you to be on-site in a location. Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes beyond traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in each of the heart arteries. Cleerly's solutions are supported by more than a decade of performing some of the world's largest clinical trials to identify important findings beyond symptoms that increase a person's risk of heart attacks. At Cleerly, we collaborate digitally and use a wide variety of systems. Our people use Google Workspace (GMail, Drive, Docs, Sheets, Slides), Slack, Confluence/Jira, and Zoom Video, prior experience in these areas is a plus. Role or department specific technology needs may vary and will be listed as requirements in the job description. While we are mostly a remote company, travel is required for some team meetings and cross function projects typically once per month or once per quarter, for some roles like sales or external facing roles travel could be up to 90% of the time. About the Team You will join our expert Computational Imaging team, where we develop sophisticated algorithms to enhance and improve medical imaging. We are focused on improving the quality and clinical value of medical images, creating powerful, extra software components that correct artifacts, standardize data, and ensure the utmost precision before the final analysis. Our work is essential for elevating the reliability and accuracy of Cleerly's regulated products. Responsibilities • Research and develop state-of-the-art AI and non-AI algorithms for coronary CT imaging applications., • Translate product and clinical requirements into algorithmic specifications in collaboration with Product and Clinical teams., • Partner with Regulatory Affairs to support regulatory submissions (e.g., 510(k), De Novo,PCCP), including generating evidence and documentation., • Collaborate with engineering teams to deploy AI and non-AI based solutions in clinical practice., • Communicate findings and strategy to internal stakeholders and leadership through clear technical documentation, presentations, and demos., • Contribute to intellectual property development through patents and scientific publications., • Ph.D. in Computer Science, Data Science, Biomedical Engineering, Biomedical Imaging, or a related technical field, with 5+ years combined postdoc and/or industry experience; OR an M.S. with 8+ years of relevant experience., • R&D experience in medical image processing, demonstrating subject matter expertise in deep learning methods for image quality enhancements, optical flow analysis and CT harmonization., • Proven track record of publications in top-tier medical imaging or computer vision conferences and journals (e.g., MICCAI, IEEE TMI, CVPR, Medical Image Analysis)., • Strong experience in Python, Tensorflow and pytorch., • Prior experience with ITK, OpenCV, VTK., • Excellent interpersonal, cross-functional, and cross-cultural collaboration skills., • 5+ years of industry experience in AI-based medical device development or clinical deployment., • Experience supporting FDA regulatory submissions for ML-based software, including familiarity with De Novo, 510(k), and PCCP pathways. *Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.). Each role at Cleerly has a defined salary range based on market data and company stage. We typically hire at the lower to mid-point of the range, with the top end reserved for internal growth and exceptional performance. Actual pay depends on factors like experience, technical depth, geographic location, and alignment with internal peers. Working at Cleerly takes HEART. Discover our Core Values: • H: Humility- be a servant leader, • E: Excellence- deliver world-changing results, • A: Accountability- do what you say; expect the same from others, • R: Remarkable- inspire & innovate with impact OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation. By submitting your application, you agree to receive SMS messages from Cleerly recruiters throughout the interview process. Message frequency may vary. Message and data rates may apply. You can STOP messaging by sending STOP and get more help by sending HELP. For more information see our Privacy Policy (). All official emails will come from @cleerlyhealth.com email accounts. #Cleerly

Job DescriptionQuality Assurance Compliance InvestigatorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the (Associate) Manager of Quality Assurance (Floor support). Responsible to perform Quality Assurance Compliance activities in support of company and/or client procedures, including but not limited to, document. management: investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality management with various department, organizational and operational excellence initiatives. Generally, exercises independent judgment, within generally defined practices and policies, when selecting methods and techniques for obtaining solutions. This role supports internal and external audits which may include interaction with Health Authorities and clients. • Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to conduct investigation and CAPA processes., • Conduct investigation and identify true root cause using appropriate tools., • Manage multiple investigations in different stages of the process to meet compliance deadlines and product release dates., • Reviews and approves investigations and CAPAs when required;, • Collaborate with cross functional department to develop and track CAPA plans., • Prepares and issues change control as necessary., • Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures., • Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations., • Conducts trend analysis of compliance related metrics such as deviations and CAPAs., • Performs supplemental investigations and/or participates in project teams or assignment as necessary., • Support in agency, internal and/or client audits., • Other duties as assigned.REQUIREMENTS, • B.S in biological sciences or other relevant field of study., • Minimum 5 years’ experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Familiar with FDA, ISO, and other regulatory agency guidelines., • Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required., • Working knowledge and technical understanding of aseptic manufacture of biologics preferred., • Experience in both clinical and commercial manufacturing is preferred., • Experience in supporting health authority inspections and/or client audits preferred., • Competencies/Candidate Profile, • Relevant computer skills (Microsoft Office, Outlook), • Detail-oriented and organized, • Analytical and problem-solving skills, • Good written and oral communication skills, • Ability to multi-task and be adaptable, • Flexible and able to adapt to company growth and evolving responsibilities, • Ability to work independently and with a team, • Strong Project Management and organization skills, • Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit., • Must be able to work in a team-oriented environment., • Must be able to work occasional weekends, nights, and/or holidays as required/necessary., • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids., • Must be able to handle the standard moderate noise of the manufacturing facility., • Must be able to work in open floor plan environment and may work in close proximity to others., • Wheel-o-Vator available for use. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description About the Job We are seeking an experienced Senior Quality Systems Specialist to join Synchron’s Quality team. This is an amazing opportunity to shape the future of Synchron’s Quality Management System (QMS) and contribute to the Culture of Quality at the company. We are looking for candidates with experience working within FDA regulated industries (preferably medical devices) and who have experience performing document control within an eQMS (preferably Arena). The ideal candidate will be detail-oriented, process-driven, and comfortable working cross-functionally in a growing company with evolving needs. Synchron is a “patient first” company full of mission-driven people. We are looking for someone who shares our passion for problem-solving and doing right by our patients. If this sounds like you, then we invite you to apply and join the team! Job Location New York, NY (on-site). Travel is generally not expected but may be needed infrequently for supplier audits. Job Responsibilities • Document Control, • Own the Document Control process, including processing change requests and executing change orders for documents inSynchron’seQMS(Arena),identifyingimprovement opportunities for the process, and educating company personnel on Document Control best practices, • eQMSAdministration, • Administer and manage the Arena electronic Quality Management System including configuration, account allocation, and license management, • Training Management, • Own the Personnel Training process in the QMS, includingdetermininginitial Quality Training needs, assigning employee Quality Training Plans, monitoring training completion,maintainingtraining records and certifications, anddeterminingaccess to theeQMSand development tools for new hires, • QMS Process Development, • Drivethe maintenance and development of existing and new Synchron SOPs/documentation to meet Synchron business needs, current regulations, and industry standards by employing industry experience and knowledge of QMSR, GLP, GMP and FDA compliance standards, • Quality Process Execution, • Own the execution of processes associated withhandling ofclinical product, including incoming inspection, inventory management, product distribution, and product returns, • Support processes including Design Control, Change Management, CAPA, Product Feedback, and Nonconformances by guiding project teams to develop recordsin accordance withinternal procedures, • Support non-product software tool assessments and validations related to the QMS, • Management Reviews, • Support Quality Management Reviews, including taking meeting minutes, preparing data and information for the review, and publishingthereview in the QMS, • Audits, • Assistwith audit preparation and execution, resolution of audit findings,interfacewith auditing groups and inspectors through all stages of audits, and perform or oversee contractorsforaudits of critical suppliers, • General, • Use continuous improvement mindset to improve quality tools and processes, • Use creative problem solving to partner with cross-functional team members to respond to and resolve issues, • Foster a culture of quality through collaboration, partnership, teamwork, and a drive for change and continuous improvement, • Bachelor’s degree, preferably in the sciencesbut we are open todifferent backgrounds, • 5+ years of experience working within a Quality Management System in an FDA regulated environmente.g.medical device,pharmaceutical,orbiotech, • We are open to candidates withvarying levels of experiencesoif you believe your skillset aligns withthe rolewestillencourage you toapply, • Knowledge and understanding of medical device Quality Management Systems and applicable regulations and standards including 21 CFR 820 and ISO 13485:2016, • Experience using an electronicQuality/DocumentManagementSystem (preferably Arena), • Demonstrated ability to perform detail-oriented work with a high degree of accuracy, • Excellenttime management,organizational,and planning skills, • Effective written and oral communication skills, • Possesses initiative and is proactive, • Must work effectively within teams with rapidly changing priorities, • Builds productive internal and external working relationships, • Experience with class III medical devices in an area such as neuromodulation, vasculardevicesor cardiac rhythm management, • Experienceparticipatingin quality inspections and performing supplier quality audits, • Experiencesupporting investigational devices undergoing clinical trials, • ISO 13485:2016 Lead Auditor Certification Compensation The base salary range for this role is $120,000– $160,000, depending on experience, skills, and qualifications. In addition to base pay, this role may be eligible for discretionary bonuses and/or equity grants subject to board approval and company policy. Work Authorization Notice Synchron hires only individuals who are authorized to work in the United States. At this time, visa sponsorship is not offered for this role. Benefits (for W-2, full-time, exempt employees in the US only) ***Intern positions not eligible • Subsidized medical and dental insurance coverage for you and your dependent(s), • Life insurance, short-term disability, long-term disability, • 401k, • Discretionary unlimited PTO, • Flexible Spending Account for you and your dependent(s), with eligible plan elections, • Commuter benefits for NY employees Equal Employment Opportunity (EEO) Synchron is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and provide equal employment opportunities without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other characteristic protected by applicable law. If you need a reasonable accommodation during the application or interview process, please let us know. Join Us At Synchron, you will be part of a transformative mission and you will work alongside driven people who believe in the power of collaboration and innovation to make a lasting impact. If you are excited to stretch your skills and contribute to something meaningful, apply and now and build the future with us.

Job Description About Amigo Amigo builds AI agents that deliver healthcare autonomously—AI doctors, AI nurses, and AI care coordinators. Our agents handle clinical workflows and patient engagement across the entire patient journey: pre-visit intake, triage, care navigation, post-visit care plans, side effect management, and medication adherence. Context-aware with memory across sessions and the ability to take clinical action. We own outcomes, not just delivery. For our customers, we're responsible for agent performance: clinical safety, continuous improvement, measurable patient outcomes. Agents operate autonomously within bounded clinical domains, with clear scope and handoff protocols. That scope expands as we validate performance across populations. We're fresh off our Series A from Tier 1 investors like General Catalyst, GSV Ventures, SVA, and CohoVC. Our work is validated with leading academic medical institutions. We're currently reaching 1M+ patient interactions every 90 days, and are on track to 10x this year. About this role As a Clinical Research Scientist at Amigo, you'll lead research on clinical AI safety, evaluation frameworks, and evidence generation. You'll design studies that validate agent performance across patient populations, develop metrics for clinical quality, and publish findings that advance the field. Your clinical expertise ensures our agents meet the standards required for autonomous operation in healthcare. This role bridges clinical practice and AI research. You'll work directly with our agent engineering and data science teams to translate clinical knowledge into measurable evaluation criteria and safety guardrails. What you'll do * Design and lead clinical validation studies for AI agent performance * Develop evaluation frameworks and metrics for clinical safety and quality * Publish research on clinical AI safety and agent evaluation methodologies * Collaborate with academic medical institutions on research partnerships * Define clinical protocols and escalation criteria for agent behavior * Review agent outputs and failure modes from a clinical perspective * Contribute to regulatory submissions and compliance documentation * Advise on clinical workflow design and patient safety considerations What we're looking for * MD or equivalent medical degree with active clinical license * Clinical experience in primary care, internal medicine, or relevant specialty * Track record of clinical research and peer-reviewed publications * Understanding of clinical quality metrics and patient safety frameworks * Experience with clinical study design and IRB processes * Ability to translate clinical expertise into technical requirements * Strong communication across clinical, research, and engineering teams * Interest in AI/ML applications in healthcare Nice to have * Fellowship or additional training in clinical informatics * Experience with digital health or health technology companies * Background in quality improvement or patient safety initiatives * Familiarity with FDA guidance on clinical decision support and AI/ML * Experience with EHR systems and clinical workflow optimization * Publications in clinical AI, digital health, or health informatics Benefits Health & Wellness * Comprehensive health, dental, and vision insurance * Mental health support and wellness coaching * Flexible wellness stipend for fitness, therapy, or personal growth * Daily catered lunch and dinner Growth & Development * Annual learning budget for courses, books, or conferences * Conference attendance budget for professional development * Development setup of your choice * Academic collaboration opportunities Compensation Range: $150K - $300K

Job DescriptionQC Analytical Compliance Investigator Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. Our client is seeking a QC Analytical Compliance Investigator to lead life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance. • Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, field complaints and environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools., • Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approach., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process., • Champion CAPA plans and implementation., • Provide communication plan for on-going deviations & CAPA’s., • Effectively create and communicate CAPA plan to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • Ability to abide by quality standards.REQUIREMENTS, • BS in a Quality / Process related field., • Experience in GMP Operations and/or QA in Cell Therapies, Biotechnology or Bio-Pharma., • Root cause analysis experience in pharmaceutical or FDA regulated operation preferred., • Experience using e-Quality Management Systems preferred., • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Flexible and able to adapt to company growth and evolving responsibilities, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • Ability to work effectively as a team and independently., • GMP Trained, Quality Systems Trained (Deviation/CAPA)Working EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy. Physical RequirementsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Non-absorbent laboratory coats are required, as well as latex (or a non-latex substitute) gloves. When working with potentially hazardous materials that may spray, aerosol, or otherwise contact skin or mucous membranes, face shields or goggles must be worn. Heavy cryo-gloves must be used when working with liquid nitrogen. Other DutiesPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Customs Brokerage Manager (Remote) Preferred: New York area (remote candidates welcome) Full-Time | Salary: $85,000–$100,000/year Join a well-established international logistics firm seeking a seasoned Customs Brokerage Department Managerto lead and manage a high-performing team of four. This is a fully remote position, ideal for a candidate with strong leadership experience in customs brokerage and hands-on entry processing. Key Responsibilities: • Oversee daily operations of the Customs Brokerage Department, ensuring compliance and efficiency, • Lead a team of four (including licensed brokers), with one upcoming retirement creating a key leadership gap, • Manage and process customs entries (approx. 325–350 entries/month), • Monitor and interpret tariff changes, customs regulations, and trade compliance updates, • Keep the department fully informed and trained on regulatory changes, • Work directly in CargoWise to manage processes and data, • Maintain departmental performance metrics and drive continuous improvement Qualifications:, • Required: Prior experience managing a customs brokerage department, • Preferred: Licensed U.S. Customs Broker, • Proficient in CargoWise software (required), • Strong knowledge of U.S. Customs regulations and HTS classification, • Willingness to be both a hands-on contributor and strategic team leader, • Excellent communication, compliance, and leadership skills Requirements Qualifications • 5–10 years of experience in customs brokerage or import operations within the freight forwarding industry, • CargoWise experience is required, • Strong knowledge of HTS classification, CBP regulations, and PGA requirements, • Experience with FDA codes, Lacey Act entries, and DDP procedures, • Excellent communication, problem-solving, and organizational skills, • Salary: $85,000 – $100,000 based on experience, • Vacation: 10 business days annually, • 401(k): 3% company contribution (eligible after 1 year, with enrollment windows on Jan 1 and July 1), • Health Insurance: Offered after 2 months of employment

Job Description Hudson Regional Health System (HRHS) seeks a results-driven and collaborative laboratory leader to oversee diagnostic and clinical laboratory operations for Bayonne University Hospital and Secaucus University Hospital. The Director is accountable for ensuring regulatory compliance, service quality, and operational efficiency across both campuses, supporting HRHS’s mission of delivering exceptional, patient-centered care. Position Summary The Director manages all inpatient and outpatient laboratory functions for Bayonne and Secaucus hospitals, including technical operations, staffing, compliance, and financial performance. The position ensures consistency, quality, and innovation across both campuses while supporting HRHS’s broader laboratory strategy. This position reports directly to the System Chief Operating Officer. Key Responsibilities • Oversee daily operations of clinical laboratory services across Bayonne and Secaucus facilities., • Ensure full compliance with CLIA, CAP, Joint Commission, OSHA, FDA, and applicable state regulations., • Supervise laboratory leadership teams, including supervisors, and technical personnel., • Maintain appropriate staffing, scheduling, and budgetary controls to ensure cost-effective performance., • Collaborate with hospital executives, medical directors, and clinical departments to support patient care initiatives., • Lead continuous quality improvement and performance optimization efforts across both sites., • Manage equipment procurement, service contracts, and laboratory supply chains., • Partner with IT and system teams to standardize data, reporting, and laboratory information systems., • Track and report KPIs, turnaround times, and quality metrics to system leadership., • Serve as the administrative and operational leader for laboratory services at Bayonne and Secaucus campuses., • Collaborate directly with the System COO and other hospital executives to align goals and share best practices., • Work closely with other HRHS laboratory leaders to advance system standardization and integration., • Bachelor’s degree in Clinical Laboratory Science, Medical Technology, or related field required; Master’s degree preferred., • Current licensure and national certification (ASCP, NCA, or AMT) required., • Minimum 7 years of progressive experience in laboratory management, including multi-site leadership preferred., • Reference Lab experience preferred., • Deep understanding of regulatory requirements, budget management, and process improvement methodologies., • Exceptional interpersonal and leadership skills, with the ability to collaborate effectively across departments.

Job Description About Our Client: Our client is a leading provider of Pharmacovigilance Technology Solutions. They bring deep expertise in drug safety, paired with advanced technology, including AI and GenAI. Their innovative solutions tackle the most pressing challenges in the pharmaceutical industry. These solutions drive both operational efficiency and enhanced business performance. Their offerings include proprietary products for automated case intake, advanced reporting platforms, GenAI-based solutions, and expert services such as Business Transformation, Safety Systems Consulting (Argus, ArisG), Data Migration, and Computer System Validation. These flexible and scalable solutions are designed to meet the needs of both large global companies and smaller organizations across diverse markets. With a focus on improving data accuracy, optimizing workflows, and ensuring patient safety, their solutions enable clients to address regulatory requirements while reducing operational costs. By streamlining complex safety processes, they empower pharmaceutical companies to drive lasting business value and maintain a competitive edge in a rapidly evolving industry. Position Overview: · Position: Principal / Associate Director / Solution Lead – Pharmacovigilance (PV) SME · Location: East Coast, USA · Experience: 15+ years Requirements Key Roles and Responsibilities: • Expertise in PV Business Processes and Safety Systems Configuration: Combine deep knowledge of Pharmacovigilance business processes with hands-on expertise in configuring PV systems (e.g., Oracle Argus Safety) to ensure that systems are aligned with both operational needs and regulatory requirements. Drive system configurations to optimize performance, data accuracy, and compliance., • Requirements Gathering & Analysis: Collaborate with stakeholders to gather and analyze system requirements, ensuring tailored configurations that meet both business and regulatory demands., • Knowledge of Global PV Regulations: Ensure compliance with regulations from major health authorities (e.g., MHRA, EMA, FDA, TGA, Health Canada, PMDA) through proper system configuration and governance., • Governance & Oversight: Provide strategic guidance on safety system updates, driving alignment with evolving business goals and regulatory standards. Lead cross-functional teams in implementing system changes and ensuring ongoing compliance., • Workflow Optimization: Continuously assess and improve system workflows to enhance efficiency and streamline operations in line with PV best practices., • Regulatory Reporting: Oversee the development of key reports, such as Aggregate Reports, Signal Detection, and KPIs, ensuring compliance with global PV regulations., • Technology Understanding: Possess a strong understanding of the technologies involved in Pharmacovigilance systems, particularly in relation to system configurations, data handling, and integration with other enterprise platforms. While not an expert-level requirement, the candidate should understand how these systems fit within the broader technology ecosystem of a PV organization., • Data Migration: Have a foundational understanding of data migration processes related to safety systems, ensuring seamless transitions between systems and accurate data transfers. Provide insights into how data migration impacts the system configurations and business processes., • BI Reporting & Analytics: Have a working knowledge of Business Intelligence (BI) reporting and analytics, ensuring that system configurations support effective reporting, including compliance and safety performance dashboards. Understand how BI tools are integrated with safety systems for real-time monitoring and reporting. Behavioral Skills: • Stakeholder Engagement: Engage effectively with cross-functional teams, regulatory bodies, and external stakeholders to ensure alignment on system requirements. Leverage strong communication and negotiation skills to manage stakeholder expectations and align configurations with business goals., • Adaptability: Quickly respond to changes in regulatory standards and business needs in a fast-paced environment. Demonstrate flexibility in adjusting to new challenges and evolving demands in the PV landscape., • Leadership: Provide leadership in cross-functional projects, mentor junior team members, and support strategic decision-making. Guide teams through system implementations and improvements, ensuring alignment with business objectives., • Critical Thinking: Apply strong analytical skills to solve complex configuration challenges while ensuring regulatory and business objectives are met. Proactively identify potential issues and develop solutions that maintain system integrity and compliance. Ideal Candidate Profile: The ideal candidate will be an expert in Pharmacovigilance business processes and Safety Systems configuration, with extensive experience in global PV regulations and requirements analysis. They should also have a strong understanding of technology, data migration, and BI reporting as they relate to PV systems, with the ability to oversee end-to-end processes and ensure compliance. This role offers opportunities for growth into senior leadership positions as the company expands globally. Why Join Our Client: Join a dynamic, people-centric environment that values ownership and accountability. We offer a nurturing culture that provides opportunities for growth and development, recognizing your contributions based on merit. You will be part of a team with decades of experience in life sciences, working on impactful projects that shape the future of industry. Collaborate with innovative technologies, drive change, and grow your career with us. Enjoy professional development, leadership opportunities, and the chance to make a real difference in a fast-evolving field. Benefits401 K Medical

Job DescriptionQuality Assurance Manager - ValidationAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. This position will report into the Associate Director of Quality Assurance responsible for the oversight and management of Quality Assurance Validation/Qualification activity. Responsible for managing the quality assurance validation activity such as development, implementation, and continuous improvement initiatives at two Allendale, NJ manufacturing sites. This role works to build, enhance, harmonize and manage quality assurance validation across sites and is responsible for finding solutions and coordinating change initiatives. Core responsibilities include, but not limited to, document management: review and approval of validation protocol, report, investigation report, assignment of CAPA, SOP development and revisions. Provides cross departmental support within Quality Assurance, as well as, collaborates with other Quality departments to support organizational and functional strategy. Develops and/or revises policies and procedures, as well as, supports operational excellence initiatives. Represents Quality Compliance in internal and external audits which may include interaction with regulatory health authorities and clients. • Functions as the sites Quality Assurance validation partner ensuring quality standards are enforced., • Partners closely with quality training staff in development of learning curriculum that drives compliance standards., • Oversees and manages the activities of validation team; provides leadership and direction to ensure that organizational and departmental goals are met., • Coordinates the investigation and closure of deviations with root cause analysis., • Ensures appropriate Corrective and Preventive Actions (CAPA) are initiated, implemented., • Manages end-to-end delivery of quality document assuring compliance of company's quality standards., • Reviews and approves GMP documents such as investigation report, CAPA, validation protocols and reports, SOPs, change controls, etc., • Reviews and proposes changes to quality agreements., • Participates in ongoing quality system improvement programs and initiatives. Establishes Quality Validation KPI Reporting and Continuous Improvement metrics., • Participates in internal audits, regulatory agencies, and client audits., • Provides technical information during tech transfer activities to ensure all quality requirements are met according to current industry standard., • Establishes departmental KPIs in alignment with organizational goals and objectives., • Plans and allocates resources to effectively staff and accomplish the work to meet departmental productivity and quality goals., • Plans, evaluates, and improves the efficiency of business processes and procedures to enhance speed, quality, efficiency, and output., • Makes business decisions that are financially responsible, accountable, justifiable, and defensible in accordance with organization policies and procedures., • Establishes and maintains relevant controls and feedback systems to monitor the operation of the department., • Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees., • Provides oversight and direction to the employees in accordance with the organization's policies and procedures., • Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities., • Empowers employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback., • Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise., • Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization., • Leads employees to meet the organization's expectations for productivity, quality, continuous improvement, and goal accomplishment., • Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning., • Provides effective performance feedback through employee recognition, rewards, and disciplinary action, with the assistance of Human Resources, as necessary., • Maintains employee work schedules including assignments, job rotation, training, vacations and paid time off, coverage for absenteeism, and overtime scheduling., • Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, Instant Messaging (IM), and regular interpersonal communication., • Supervise 1-2 Direct Reports, • Other duties as assigned.REQUIRMENTS, • Bachelor of Science in biological sciences or other relevant field of study., • 5-10 years’ relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments. 3+ years of recent supervisory experience required. Experience in both clinical and commercial manufacturing is preferred., • Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (investigation, validation/qualification reports, SOPs etc.), • Experience in organizing and leading teams., • Experience participating in health authority inspections and/or client audits., • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task team is essential, • Flexible and able to adapt to company growth and evolving responsibilities., • Training; GXP, SOP & WI training, Safety, • Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit., • Must be able to foster and work in a team-oriented environment., • Must be able to work infrequently on weekends, nights, and/or holidays as required/necessary., • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids., • Must be able to handle the standard moderate noise of the manufacturing facility., • Must be able to work in open floor plan environment and may work in close proximity to others., • Wheel-O-Vator available for use., • Small breakroom available. No on-site cafeteria available.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Manager-Director, Business Development - Clinical Research Manager-Director, Clinical Business Development Full Time Remote-USA Based (Preferably East Coast) Reports to: Senior Vice President, Clinical Services Frontage Laboratories Inc. Frontage Laboratories Inc. (Frontage) is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several different locations within the USA, Canada, and China. Frontage’s core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, clinical research, and core laboratory services for clinical trials. Frontage Clinical Services At Frontage, we leverage more than 25 years of experience to develop a unique approach to overcome the challenges of every clinical study, while maximizing efficiency and mitigating risk. We apply best practices in study design and execution to advance each study to completion. Position Summary: The Business Development role involves the creation of long-term valued business relationships for the Company with both existing and new customers, with primary emphasis on new account development. The position title can be Business Development Manager to Director depending on experience. Responsibilities: • Secure and retain business through professional, consultative, and proactive sales activities directed at key decision makers., • Strong negotiating skills, knowledge of legal contracts and experience with RFIs/RFPs and competitive bidding processes., • Analyze potential opportunities and develop sales plans for each target account, develop in-depth knowledge of the customer organization., • Ensure appropriate strategy/solution is proposed to clients., • Monitor actions and results against plans., • Lead client visits to the Frontage facilities., • Coordinate with scientific and operations staff to prepare and lead the sales presentations, present comprehensive proposals, and lead follow-up activities., • Monitor sponsor satisfaction by regular communication with the clients/sponsors., • Record all client/sponsor sales related (opportunities, CDA, MSA, Site Visits, Face to Face Meetings, etc.) activities in CRM (salesforce) system., • Represent Frontage at trade shows and other meetings. Education, Skills and Experience Required: • BS degree or above, life science preferred., • Must have 2+ years’ experience in selling Pre-Clinical or Phase 1 clinical research services., • Solid understanding of the principles of drug discovery and development., • Knowledge and experience in DMPK & Safety Toxicology, • Knowledge and understanding of FDA, GCP, and ICH regulations and guidance, • Highly proficient in using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel., • Attention to detail and ability to work simultaneously on multiple priorities. Able to adapt and be flexible to changing priorities., • Excellent oral and written communication skills., • Ability to travel., • Established industry client network is a plus. Salary and Benefits: Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Job Description About Quest International For over 40 years, Quest International Inc., headquartered in Irvine, California, has partnered with healthcare organizations, Fortune 500 companies, and technology leaders to support critical medical, industrial, and IT equipment. We specialize in medical and industrial display systems, field engineering services, preventative maintenance, repairs, and logistics programs that keep essential technology operating reliably. Our success is driven by our people. Quest fosters a culture built on accountability, technical excellence, collaboration, and continuous learning. We invest in hands-on training, professional development, and real-world experience to help our field teams grow and succeed. Quest International maintains ISO-certified quality standards and participates in the United Nations Global Compact, reflecting our commitment to safety, sustainability, and ethical business practices. When you join Quest, you become part of a mission-driven organization supporting industries where reliability and performance truly matter. About the Role The Field Service Engineer – Medical & Industrial Systems (New York) is a hands-on, field-based role responsible for installing, maintaining, troubleshooting, and repairing electro-mechanical equipment in hospital, laboratory, and industrial environments. This position is not an IT or help desk role. Work is performed on-site and involves physical interaction with equipment, including installation, preventative maintenance, and repair activities. Candidates seeking remote, software-focused, or desktop IT positions will not be a fit. The role requires independence, strong troubleshooting ability, and comfort working directly with customers in regulated environments. Extensive travel is a core requirement of this position. Compensation, Schedule & Travel * Pay Range: $24.00 – $29.00 per hour (DOE) * Employment Type: Full-time, non-exempt * Typical Schedule: Monday–Friday, daytime hours * On-Call: Participation in an on-call rotation for urgent service needs may be required * Travel Requirement: Approximately 80% travel, primarily regional with overnight stays as needed * Coverage Area: New York-based field coverage (home-based when not traveling) Key Responsibilities * Install, service, and maintain medical and industrial electro-mechanical equipment * Perform preventative maintenance and corrective repairs per manufacturer documentation * Troubleshoot systems to the FRU level using standard service tools * Support customers on-site and clearly explain technical findings and actions * Maintain accurate service documentation and reports * Coordinate parts usage, replacements, and shipments * Participate in on-call rotation and support urgent service needs * Follow all safety, quality, and compliance requirements in regulated environments Minimum Qualifications * Technical background in electronics, electro-mechanical systems, biomedical equipment, or industrial maintenance * Hands-on field service experience with electro-mechanical equipment * Ability to troubleshoot electrical and mechanical systems independently * Willingness and ability to travel extensively (up to ~80%) * Valid driver’s license and ability to rent a vehicle (Bachelor’s degree not required if equivalent hands-on experience is demonstrated) Preferred Qualifications * Experience working in hospitals, laboratories, or regulated industrial environments * Familiarity with preventative maintenance programs and service documentation * Experience using diagnostic tools such as digital multimeters and related test equipment * Knowledge of FDA, ISO, or OSHA-regulated environments * Medical device, imaging, or industrial equipment exposure Physical & Work Environment Requirements * Ability to stand, bend, climb, crawl, and work on equipment for extended periods * Ability to lift up to 50 lbs, assisted or unassisted * Comfort working in hospitals, labs, factories, and other regulated environments

Job DescriptionThe incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • Bachelor’s Degree in a Scientific or Engineering discipline, • 8 + years of computerized system experience with IT compliance/validation/qualification activities., • 8 + years of experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • 10% travel required., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionAbout CookUnity: Food has lost its soul to modern convenience. And with it, it has lost the power to nourish, inspire, and connect us. So in 2018, CookUnity was founded as the first-of-its-kind platform that connects the world with the source of truly great food: chefs. Today, CookUnity delivers 50 million meals a year from the industry's best chefs to homes all over the country. Fresh. Ready-to-eat. And crafted with the passion that nourishes body and soul. Unwilling to stop there, CookUnity is expanding beyond delivery to become an ever-innovating marketplace focused on our singular mission: empower Chefs to nourish the world. If that mission has you hungry in more ways than one, you've found the right job posting. The Role: The Food Safety Specialist ensures a sustainable, safe, clean, and functional environment in the CookUnity Commissary. Responsibilities: • Monitor food production and ensure all Chefs are adhering to food safety regulations, • Perform critical checks including refrigeration, chemical concentration and and temperature checks, • Communicate kitchen rules to Chefs as needed- gloves, hairnets, proper hand washing, cleaning of equipment, sanitizing of prep stations, etc., • Ensures all items in coolers and freezers are appropriately labeled. (Labels must include Chef Name, Product Name and Date), • Daily facility compliance walks including corrective actions, • Work closely with other departments such as Kitchen Operations, Supply Chain and Maintenance to correct issues affecting food safety and quality., • Ensure the facility is always ready for inspection by local regulator or third party auditor, • Ensure all walk-in coolers and stand alone fridges remain closed and temperature is at 41 degrees or lower, • Perform weekly thermometer calibrations for Chefs and Food Safety team, • Collaborate with other members of Food Safety team in Chef and employee training on food safety and sanitation topics, • Perform facility and department audits, • Collect and provide data on cooler function and sanitary transport to operations and facilities teams Minimum Requirements: • Experience working in a high compliance food processing facility (USDA, FDA), • Positive and committed to doing the right thing, • Experience working with a team in a fast paced environment, • Good communication skills and ability to speak in a professional manner to a wide range of partners and stakeholders, • Ability to build relationships and explain food safety concepts in plain language, • Ability to work independently and complete assigned duties without direct supervision, • Proficiency G Suite/Google Workspace., • Team player with a positive, collaborative mindset, • Ability to work 30-40 hours per week., • Flexible availability for one of the following shifts: 6:00 AM to 2:00 PM, 2:00 PM to 10:00 PM, or 10:00 PM to 6:00 AM, • Bilingual English/Spanish required Benefits 🩺 Health Insurance coverage 🌅 401k Plan ⛱ Paid sick days 🐣 Family leave: 12 weeks for primary caregiver and 6 weeks for secondary caregiver, fully paid 🕯 Compassionate Leave: 3-5 days each time the need arises 🌟 Awesome opportunity to join a company that is looking to change how we eat and how chefs work! Compensation All final pay rates will be determined by candidates experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data.Pay Range for this position$20—$26 USD If you're interested in this role, please submit your application, and if we think you might be a fit, we'll get in touch with you. Thank you for your time! CookUnity is an Equal Opportunity Employer. We are dedicated to creating a community of inclusion and an environment free from discrimination or harassment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, citizenship status, protected veteran status, genetic information, or physical or mental disability. A quick note for all candidates We've recently seen an increase in recruitment scams across the industry, and we want to make sure you (and your data) stay safe while applying to CookUnity. We also want you to know that we take this seriously — sometimes, as part of our process, we may ask for a brief "proof of humanity" to confirm that we're connecting with a real person, not an impersonator. Here are a few tips to help you protect yourself and know what to expect from us: • Apply only through our official channels. All open roles are listed on our official careers page: careers.cookunity.com, • Our recruiters are real people — and easy to verify. You can always find them on LinkedIn with verified profiles. If you're unsure, feel free to reach out to us on our official LinkedIn Company Page., • We only communicate through official CookUnity channels. That means emails ending in @cookunity.com and interviews held through official company platforms (Google Meet or Zoom) — never WhatsApp, Telegram, or SMS.

Job Description HearUSA is a leader in hearing healthcare. We are on a mission to make hearing care simpler and more accessible than ever before, setting a new standard in modern hearing care. We are taking a stand and reducing the stigma around hearing loss. We draw on the expertise and hearing care services of more than 360 hearing centers across the U.S. Our hearing center teams change lives by giving clients easy access to advanced hearing technology and outstanding care. HearUSA is also part of the WS Audiology (WSA) family, a global leader with over 11,000 employees in 125 markets and 2 global headquarters. ESSENTIAL DUTIES AND RESPONSIBILITIES: • Perform comprehensive hearing evaluation, hearing aid selection and fitting for all clients, employing best practices as defined by our client-centric service model of Simply Excellent Hearing Care. Meets minimum NPS score of 75., • Routinely demonstrates hearing aids as part of annual evaluations for clients to experience the sound and create the ‘wow’ moment of a personalized auditory simulation., • Evaluate test results in conjunction with client needs' assessment to make a personalized recommendation. Offers recommendation based on maximizing client benefits., • Perform routine follow-ups, clean and checks and hearing aid repairs. Maintain skills in ear impression taking, earmold modification and recommendation of ALD accessories., • Embody HearUSA's ambition of Changing Lives through Simply Excellent Hearing Care. Partner with the District manager, HCP Team Leads and L&D to adopt new initiatives aimed to grow your Center's revenue and change more lives., • Build a local community to proactively generate service demand and support marketing campaigns, such as to physicians and at health fairs. Successfully completes one community outreach and/or physician marketing per quarter., • Comply with all State license laws, FDA guidelines, WSA policies and HearUSA Quality Practice Guidelines (QPG). Operates in a HIPAA compliant manner, with documentation, outcome notes and referrals completed for all clients., • Engage in Continued Professional Development to maintain expertise in all aspects of service delivery, from consultative counseling to the selling, fitting and troubleshooting of current hearing aid technology., • Embraces our culture and values of Going Beyond Together, Pioneering for Better Solutions, and Passion for Impact.REQUIREMENTS:, • Experience in a similar Audiology or Hearing Aid Specialist role., • Active state license in Audiology and/or hearing aid dispensing., • 1-5 years of experience preferred., • Ability to pay close attention to detail with a high degree of accuracy., • Basic or advanced written communication skills., • Experience interacting with customers/clients., • Ability to communicate detailed or technical information clearly, accurately and concisely., • A structure of field support for your hearing center, • A professional development team of dedicated Regional Training Managers, • Continuing education, LinkedIn Learning & licensing reimbursement, • Career advancement pathways such as Hearing Care Provider and Client Experience Specialist Team Lead, Hearing Care Provider Advisory Board member, or District Manager, • Monthly Commissions, • CEUs & State Licensure Renewals for HCPs, • Defined Career Paths, • Sponsorship & Preceptor Opportunities, • President’s Club Incentives, • Employee Referral Program LIFESTYLE & BENEFITS:, • Comprehensive Benefits Package, • Paid Holidays & PTO Policy, • 401k Matching Program, • Tuition Reimbursement, • Employee, Family & Friends Hearing Aid Discount Program The Company provides equal opportunity to all employees and prospective employees without regard to race, color, creed, religion, national origin, ancestry, sex, age, physical or mental disability, marital status, pregnancy, genetic information, sexual orientation, gender identity, protected veteran or military status, or any other consideration not related to the person’s ability to do the job or otherwise made unlawful by federal, state, or local law.

Job DescriptionSupplier Quality AuditorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Supplier Quality Auditor ensures and promotes compliance through external auditing of company's suppliers; vendors/ laboratory services/service providers/manufacturers for the Allendale, NJ and Mountain View, CA sites based on company's procedures and external regulatory requirements, including but not limited to current FDA Quality System Regulations; 21 CFR Parts 210/211 (cGMP), 21 CFR Part 1271 (GTP), 21 CFR Parts 50/54/56/312 (GCP), 21 CFR Pat 58 (GLP), ICH Q7, Q9, Q10, 21 CFR Part 11 and Data Integrity and Eudralex Volume 4 Guidelines.The Supplier Quality Auditor position will be responsible for the development of a risk-based auditing program for company and management of the Approved Supplier List. The Supplier Quality Auditor will conduct external supplier/vendor/manufacturer audits and harmonize the supplier qualification process across all sites. The Supplier Quality Auditor supports qualification initiatives, continuous improvement, and regulatory compliance across all sites. • Develop and maintain a risk-based external auditing program for company harmonized across all sites., • Perform GAP analyses of the Approved Supplier List (ASL) of suppliers used at all company facilities to ensure complete profile., • Management of ASL to add suppliers and maintain approval status of all suppliers as needed., • Based on ASL status, conduct reviews and perform audits to qualify each supplier used., • Prepare external audit schedule and conduct audits per the schedule., • Prepare and complete audit reports and communicate audit information to cross functional teams within company and supplier within a timely manner., • Ensure adequate CAPAs are developed by suppliers and monitor CAPA closures., • Track audit findings for suppliers to completion and ensure timely closure of audit reports., • Act as a quality lead and liaison between suppliers and internal teams to identify new suppliers and identify and communicate issues that may impact quality, system gaps or cause interruptions in business continuity., • Maintain metrics on supplier audit findings used for oversight, qualification status, continuous improvement, and/or opportunities for reduction/alternate suppliers., • Maintain audit files and ensure all files are properly archived., • Author and review External Auditing, Supplier Qualification and Supplier Management Program and/or Quality Systems SOPs, as needed., • Ensure that Quality Agreements are generated and enforced at each supplier., • Ensure and promote compliance with applicable regulations (e.g., cGMPs, GTPs, etc.) and company and client SOPs., • Assist in other Quality System related responsibilities and provide Quality related support to various departments, as needed.REQUIREMENTS, • Minimum 5-8 years quality systems auditing experience in pharmaceutical, biologics, or medical device industry., • Auditor qualifications and certifications such as Certified Quality Auditor (CQA)/ASQ Certification, ISO Certification, etc., • Experience with auditing raw materials/excipients, components, and analytical and micro laboratories., • Proven ability to identify, collaborate, and resolve supplier related compliance issues., • In-depth knowledge and understanding of current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), ICH Q10, 21 CFR Part 11, Good Tissue Practices (GTPs) and Data Integrity principles,, • EU and PMDA regulations knowledge and associated guidelines are a plus., • Bachelor’s Degree in the chemistry or biological sciences, engineering, or life sciences., • Certified Auditor or Lead Auditor credentials required., • Understanding of the manufacture and testing of cellular and gene therapies is desirable., • Working knowledge of routine laboratory operations, equipment and systems, production processes, and validation., • Experience in Quality Assurance, including the ability to identify and resolve compliance issues., • Sound knowledge of aseptic processing and supporting technologies., • Must have exceptional written and oral communication skills., • Exhibit professional mannerisms when dealing with Clients/Suppliers and company personnel, • Ability to multi-task is essential., • Proficiency with IT skills, such as MS Office (Word, Excel, Outlook, PowerPoint) and SharePoint., • Ability to think strategically and tactically (strong detail-oriented)., • Strong collaborative and influencing skills and ability to work well in a cross-functional, team matrixed environment as well as independent contributor., • Strong analytical and problem-solving skills., • Flexible and able to adapt to company growth and evolving responsibilities., • Multi-disciplinary knowledge across GxP functional areas., • Excellent organizational skills including efficiency, punctuality and attention to detail and managing multiple priorities., • Good verbal, written communication, and presentation skills., • Demonstrable multitasking, project management, and execution skills., • Good business acumen and strong team-oriented interpersonal skills, including communication, presentation, negotiation, influence., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to handle the standard/moderate noise of the manufacturing facility, • Travel required (approx. 50%)Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionAbout Sunrise Group Sunrise Group is building the future of sleep health by combining breakthrough technology with expert care. We started in 2015 with a straightforward idea: sleep diagnosis should happen in the comfort of your own home, not in a hospital. To make that possible, we created a first-of-its-kind chin sensor, carefully validated through clinical research, reviewed by leading sleep experts, and cleared by the FDA. Since then, Sunrise Group has grown from a single innovation into a complete sleep health company. We now design advanced diagnostic and treatment solutions, and we deliver care directly to patients through Dreem Health, our digital sleep clinic. By serving patients in all 50 states with reimbursed care, we are making sleep treatment more accessible, more personal, and much simpler than it has ever been. Your Opportunity As a Territory Manager at Dreem Health, you'll be out in the field every day, building trusted relationships with physicians, specialists, and clinics to drive referrals to our digital sleep clinic. You'll promote our life-changing sleep care services, especially for patients with sleep apnea, by educating providers, organizing lunch & learns, and creating awareness across your territory. You'll track referral activity, share insights with internal teams, and play a hands-on role in shaping how we grow. This is a high-impact opportunity for someone who thrives on connection, loves being on the go, and wants to be part of a mission-driven team transforming access to care. Note: While everyone is welcome to apply, we are currently prioritizing applicants that live in the following cities: • CA - Must live in the San Jose Greater Metropolitan Area, • TX - Must live in Houston or Dallas (not Forth Worth)What You Bring, • 2+ years in healthcare, either in partnerships, provider relations, or sales, • Bachelor's degree in Business, Healthcare Administration, or related field, • Valid Driver's License and clean driving record, • Strong understanding of healthcare referral processes, • Experience with CRM systems (we use Hubspot) and data reporting tools, • A genuine passion for improving healthcare access and patient outcomesWhat Makes You Stand Out, • Existing network of primary care providers, • Knowledge of sleep health, mainly sleep apnea, • Exceptional relationship-building and communication skills, • Strategic and entrepreneurial approach to territory management, • Adaptability in a fast-growing healthcare and tech environment, • Be part of an international team across the US and Europe, • Comprehensive health benefits (medical, dental, vision), • 401(k) with company match, • 20 days PTO + 10 paid holidays + sick leave, • FREE One Medical membership We hire humans, not bullet points. Don't meet every single qualification? That's okay. We care more about who you are than what's on your CV. We're looking for people who are curious, resourceful, and ready to roll up their sleeves — especially if you're excited about building something new in healthcare. So if you think you could make an impact here, reach out to us. Dreem Health / Sunrise is an Equal Opportunity Employer. We welcome people of all backgrounds and are committed to building a workplace where everyone feels included and respected. We do not tolerate discrimination or harassment of any kind.

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 Medical Science Liaison (MSL) / Senior Medical Science Liaison (Sr. MSL) at Compass Pathways is a core member of the Medical Affairs organization, connecting the company's science with the broader mental health and neuroscience community, helping to shape medical strategy, and supporting the continued development of Compass Pathways' work in treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). This role is responsible for developing and managing a geographic territory and serving as a key scientific point of contact through both virtual and face-to-face interactions. The ideal candidate is passionate about a field-based role establishing themselves as a key point of scientific contact, actively engaging in high-quality scientific exchange and gathering insights from the field on emerging research, changes in the treatment landscape, and evolving approaches to care. Reports to: Director, Medical Science Liaisons. Location: Remote in NY Metro+ (Manhattan, Long Island, Brooklyn, PA, NJ, MD, DE) or hybrid in our NYC office. Roles and responsibilities: (include but not limited to) • Develop and maintain scientifically grounded relationships with healthcare professionals, researchers, and thought leaders across neuroscience and mental healthcare within the assigned territory, • Lead in-depth, compliant scientific conversations focused on disease understanding, research methodology, and emerging evidence in treatment-resistant depression and PTSD, • Anticipate and address scientific questions from external stakeholders by providing accurate, balanced medical information in response to unsolicited requests, • Collect, analyze, and communicate medical insights from the field to internal stakeholders to inform clinical development, medical strategy, and educational planning, • Maintain a high level of scientific expertise in relevant therapeutic areas, competitive landscape, and emerging research through continuous -- sometimes self-guided -- learning, • Contribute to the planning and execution of medical education activities, advisory boards, and scientific congress engagements and presentations, • Uphold all ethical, regulatory, and compliance requirements in the conduct of field medical activities, • Collaborate cross-functionally with internal partners (e.g., Clinical Development, Government Affairs, Market Access), • Provide training to eventual sales and marketing teams, • For Senior MSLs: mentor and coach junior MSLs, support onboarding and training efforts, and contribute to broader medical affairs initiatives or special projects Candidate Profile: • Advanced scientific training with associated credentials (e.g., PhD, PharmD, PMHNP, MD), • Previous MSL experience is strongly preferred, • Preference for candidates with background/experience in neuroscience, psychiatry or psychology, • Ability to travel up to 75%, including overnight stays and weekends, as needed, • Candidate must reside within the geographic area, • Engaging and expert communicator of scientific information and representing core values to a diverse array of audiences, • Excellent verbal and written communication, listening skills, and emotional intelligence, • Proven experience of self-motivation, accountability, integrity & teamwork 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 Description Location: This role is onsite at CPMI in Miami, FL If you are not local to Miami, let's discuss how to get you there! This is a newly created role at an amazing, top clinical research site located in Miami, FL About Company: Who is ERG? ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late-stage neuroscience drug development. With 19 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally. About the Role: We are seeking a highly qualified Manager/Director of Clinical Operations, Phase I, to oversee clinical trials, ensuring protocol adherence, and managing both staff and operational aspects of studies. This role demands strict compliance with GCP, ICH guidelines, and company SOPs. Core duties include staff management, protocol review, quality assurance, and overall study supervision. Responsibilities: • Lead and mentor the clinical operations team to promote a collaborative and efficient environment., • Ensure protocol compliance and maintain high-quality standards across studies., • Collaborate closely with Principal Investigators and Site Directors to assign studies and develop enrollment strategies., • Oversee human resources functions, including staff evaluations, recruitment, and training., • Monitor adherence to protocols, reporting any deviations to sponsors and regulatory bodies., • Coordinate with Site Director and Principal Investigator to assign primary clinical research coordinators., • Review study components with Principal Investigators and Site Directors, identifying areas requiring clarification before study initiation., • Conduct study closeout procedures., • Perform additional duties as needed to adapt to the evolving needs of CPMI., • Bachelor's degree in a scientific or healthcare-related field, • 7-10 years of experience in clinical operations, including 5+ years in a senior leadership role., • Strong understanding of FDA, ICH, and GCP regulations and guidelines, • Strong communication, organizational, and leadership skills., • Ability to travel as needed and proficiency in Microsoft Word, Excel, and clinical management software., • In-depth knowledge of clinical trial operations, including study start-up, site selection, patient recruitment, monitoring, data management, and study close-out, • Phase I or early phase experience Our comprehensive benefits package includes: • Health insurance, • Dental & Vision Insurance, • Matching 401k Retirement Plan, • Paid Time Off (PTO)

Job DescriptionAbout Project Healthy Minds Project Healthy Minds is a mental health nonprofit that runs like a tech startup. We are pioneering a first-of-its-kind model: applying technology to address one of the biggest social issues of our time: the growing mental health crisis. We believe in a simple but profound idea: that it should be as easy to find mental health services as it is to book a flight or a restaurant reservation. That's why we're building the world’s first digital marketplace for finding mental health services that are right for you. To do that, we work with some of the most inspiring and influential leaders in America - business titans, tech entrepreneurs, clinicians and scientists, musicians, artists, athletes, media stars, policymakers, and more - because we believe that the world's most complex challenges require interdisciplinary teams and solutions. We are backed by a powerhouse of industry-leading Board of Directors and Advisory Council Members who are passionate, hands-on, and dive into the important work with us. Learn more at projecthealthyminds.com and @projecthealthyminds on social. About The Role WHAT WE'RE LOOKING FOR The Lead Product Designer is a core member of the product team and owner of the product design practice at Project Healthy Minds, ensuring that we ship accessible, intuitive, and emotionally resonant digital experiences that meet user and business needs. This is a full-time, in-office position. HOW YOU'LL CONTRIBUTE

Job DescriptionCompany Description EVERSANA INTOUCH® is a global, full-service marketing agency network serving the life sciences industry, and is the first – and only – agency network to be part of a fully integrated commercialization platform through EVERSANA®. We provide next-generation creative and media services, enterprise solutions and data analytics services for clients. We get fired up when people talk about getting—and staying—healthy. That’s where we find our inspiration: in the very human experiences of patients, doctors, and even each other. Then, we collaborate on ways to make caring for one’s health more achievable, connecting patients and physicians with the information and tools they need. We embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. Job Description THE POSITION: The Associate Director, Medical has a deep understanding of the client’s business and demonstrates critical thinking and confidence while distilling the scientific and clinical data of the client’s brand(s), their competitors and clinical landscape into meaningful insights and strategic recommendations. This individual has the courage to take ownership and produces quality deliverables over multiple assignments, often concurrently. Your grasp of the scientific literature and ability to assimilate and transpose data beyond the context of the brand label are the keys to making recommendations to help solve complex business challenges. ESSENTIAL DUTIES AND RESPONSIBILITIES: Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by: * Provide strategic input to guide creation of clinically relevant educational content and ensure effective use of clinical data to reach strategic brand objectives * Independent scientific content development including analysis and interpretation of clinical data across a wide range of project types * Conduct literature searches, proactively monitor competitive landscape and perform competitive analyses * Establish strong relationships with clients and proactively seek to contribute and collaborate in client meetings * Partner with internal teams to create compelling peer-to-peer educational content and engagement projects for healthcare professionals, including slide decks, KOL video, digital and print media * Establish close partnership with copy, art and digital teams to create interactive, engaging programs utilizing scientific storytelling techniques and unique data visualization * Collaborate to create and communicate Intouch’s POV and recommendations with clients * Play key role on team to educate team members on disease state, clinical trials, treatments and competition * Support submissions for client medical/regulatory approval processes and partners with all teams to incorporate client and regulatory feedback * Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias. * All other duties as assigned Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by an employee with a disability, unless such accommodation would cause an undue hardship for EVERSANA. If reasonable accommodation is needed to perform the essential functions of your job position, please contact Human Resources. PEOPLE LEADER: People leaders must possess both the skills to effectively accomplish these tasks and the emotional intelligence to do so in alignment with our cultural values. In addition to the critical management and leadership tasks listed above, this role also includes the following unique responsibilities: * Responsible for and oversee their respective department. * Interview, select and supervise the activities of the department staff; communicate interpret and discuss with team the company policies and procedures. * Determine job objectives, work methods and performance standards; review performance relative to departmental objectives discussion appraisal with each employee and performance; authorize and communicate salary changes, promotions, transfers, discipline, and discharge and administer all other personnel actions. Qualifications MINIMUM KNOWLEDGE, SKILLS AND ABILITIES: The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required. * Advanced degree (PhD, MD or PharmD) in medical sciences related field required * Preferably two or more years of agency experience in medical education, medical communications and/or HCP marketing * Strategic thinker that understands how to effectively tell a scientific story in a compelling way to differentiate client products * Two years minimum medical writing experience required * Experience creating branded or unbranded peer-to-peer educational content * Expertise in extracting relevant information from clinical sources and writing medically accurate copy * Excellent verbal, written and organizational skills * Client-facing confidence that advances dialogue and creates strong agency-client relationships * Experience with complex projects that require collaboration between internal and external teams including key opinion leaders * Familiarity with FDA marketing regulations, AMA editorial style and digital PREFERRED QUALIFICATIONS: * Positive, problem-solving attitude * Someone who likes to have fun! Additional Information OUR CULTURAL BELIEFS: • Patient Minded I act with the patient’s best interest in mind., • Client Delight I own every client experience and its impact on results., • Take Action I am empowered and empower others to act now., • Grow Talent I own my development and invest in the development of others., • Win Together I passionately connect with anyone, anywhere, anytime to achieve results., • Communication Matters I speak up to create transparent, thoughtful and timely dialogue., • Embrace Diversity I create an environment of awareness and respect. EVERSANA is committed to providing competitive salaries and benefits for all employees. If this job posting includes a base salary range, it represents the low and high end of the salary range for this position and is not applicable to locations outside of the U.S. Compensation will be determined based on relevant experience, other job-related qualifications/skills, and geographic location (to account for comparative cost of living). More information about EVERSANA’s benefits package can be found at eversana.com/careers. EVERSANA reserves the right to modify this base salary range and benefits at any time. From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility. Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by a qualified applicant or candidate with a disability, unless such accommodation would cause an undue hardship for EVERSANA. The policy regarding requests for reasonable accommodations applies to all aspects of the hiring process. If reasonable accommodation is needed to participate in the interview and hiring process, please contact us at . Follow us on LinkedIn | Twitter

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 . The R&D Formulation Manager/Principal Scientist will lead the design, development, and implementation of novel formulations and polymer materials for use in medical devices, ensuring all activities meet quality and regulatory standards. This role involves providing expertise in formulation development, building and optimizing internal capabilities to deliver innovative and efficient solutions, and ensuring alignment with the company’s long-term technical vision to create a strong pipeline of customer-focused innovations. Key responsibilities include developing and characterizing formulations, recruiting and onboarding talent, managing technical collaborations with external suppliers and vendors, and integrating formulations into scalable manufacturing processes, whether in-house or through CDMOs. This role operates in a collaborative, cross-functional environment, requiring flexibility, a strong focus on scientific formulation, and a drive to explore new technologies and techniques in pursuit of robust, innovative materials and products. This is a senior technical role overseeing a small team. The R&D Formulation Manager/Principal Scientist is expected to be a subject matter expert in areas including polymer material science, formulation strategies, analytical chemistry, and biomaterial interactions with biological systems. They are responsible for ensuring high standards in research practices. They are responsible for leading the creation of documentation required for regulatory submissions, developing strategies for grants and publications, and securing non-dilutive funding through grant opportunities. They will report to the Vice President Technology. This is a full-time, on-site position, located in Brooklyn, New York. Responsibilities • Lead, staff, and manage formulation development teams and their efforts across multiple parallel product development opportunities, to launch new commercially successful products., • Provide sound scientific leadership, monitoring, and coaching through the initiation, planning and execution their team’s overall activities., • Create and lead experimentation for exploratory and/or product development research with focus on polymeric materials and their use., • 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., • Lead material/design/process changes through design control process, with well-documented research/analyses., • Review and author protocols and reports including development studies and design verification/validation activities., • Develop and implement investigations into new technologies and capabilities, partnering with business development, that advance research team and company objectives., • Lead efforts in chemical and mechanical property evaluation to assess the desirability of process or formulation changes. Develop test method capabilities to support R&D (exploratory research, product development) and production test requirements., • Develop unique, proprietary (and ideally patentable) intellectual property that yields competitive advantage., • Lead and participate in voice-of-customer (VOC) labs and influence go-to-market strategies., • Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication., • Work as part of a cross-functional team to develop, verify, and validate product designs through bench, in-vitro, and in-vivo testing and other assessments., • Ensure an effective documentation system is in place and utilized throughout the development process inclusive of R&D lab notebooks, design reviews, test methods, and test reports., • Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions,, • Act as research liaison between R&D and Quality Control to define product specifications., • Maintain active dialogue with Manufacturing to ensure successful technology transfer and process development, including the review of research-related documents, • Provide guidance and support to commercial teams, support introduction of new technologies with 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., • 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 • Master’s degree in Chemistry, Materials Science, Chemical Engineering, Polymer Science, or a closely equivalent discipline., • A minimum of 10 years of research experience in developing and utilizing polymeric materials, biomaterials, or other complex materials toward product/application development and their manufacture, with at least 5 years in a non-academic setting., • A minimum of 2 years of direct management experience., • Adept experimentalist with hands-on research experience with polymers, coagulation chemistry, and materials science of complex systems, including the development of structure-property performance relationships in designing and characterizing these materials., • Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet the application requirements, along with a fundamental understanding of the chemistry that drives the performance required. This includes strong analytical, problem-solving, and decision-making skills with the ability to be observant and to think creatively., • Direct experience in new product development from concept to regulatory approval through launch., • Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies is required., • Excellent verbal and written communication skills, with the ability to lead in a dynamic and collaborative environment is required., • Highly organized and detail-oriented, with the ability to extract key facts from complex information and create/present clear and concise technical documentation is required., • Demonstrated ability to lead and inspire teams and develop and mentor individuals, and allocate resources strategically and according to the portfolio priorities., • Requires strong leadership and organizational skills with a strong attention to detail and multi-tasking skills while simultaneously keeping overall “big picture” view of projects, priorities, and strategies., • Experience working under pressure with tight timelines, with the ability to maintain a sense of priorities, focus, urgency, and delivery., • Strong working knowledge of Microsoft Office., • Legal authorization to work in the United States. Preferred Qualifications • Ph.D. in a relevant discipline is strongly preferred., • Experience developing and commercializing products in a highly regulated environment, • Medical device development experience., • Demonstrated expertise in the use, development, and qualificication of material characterization techniques, including rheological, thermal, mechanical, spectroscopic, microscopic, and other chemical compositional methods., • Strong understanding of medical device regulatory requirements for Class II and III medical devices (e.g., 21 CFR Part 820), cGLP/cGMP, and related standards (e.g., ISO 13485)., • Strong understanding of cGMP, ICH guidelines, • Six sigma green belt or black belt certification., • Experience with executing a grant and publication submission strategy, knowledge of and strong track record with SBIR submissions to multiple agencies, including NIH and DOD is strongly preferred., • Demonstrated experience in Project Management and Product Lifecycle Management practices, and the ability to lead multiple projects simultaneously., • Excellent problem-solving skills and a proactive approach to addressing formulation challenges. 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 BENEFITS • Competitive annual base salary range of $130,000 - $180,000, depending upon 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, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%

Job DescriptionAt Rowan, we are all about making ear piercing experiences a celebration full of joy! Rowan is an innovative ear-piercing and hypoallergenic jewelry brand that brings safety to the forefront with our team of licensed nurses – and celebration to every customer with our joyful approach to piercings and jewelry. Our priority is to offer a fun, celebratory, and safe ear piercing experience for everyone. When we say piercing for all, we mean it. Everybody is invited to this ear party! Retail Associate Buyer who is detail oriented to manage the recommendation on assorting and selection of jewelry and ear piercing products. This role reports directly to the CSCO and requires a strong understanding of consumer preferences, and quality materials, metals and gemstones in the jewelry space. The ideal candidate will play a key role in supporting the curating of a compelling product assortment that aligns with our brand identity and incorporates a deep understanding of our customer—not just market trends, but the specific styles and preferences of those we serve through our piercing services. By leveraging direct customer interaction and store team insights, this individual will make informed, customer-first buying decisions that reflect customer demand and enhance the post-piercing experience.Strategic Buying & Merchandising • Execute the approved seasonal buying strategies that align with company revenue goals and fashion trends partnering with vendors to produce the best products at targeted company costs, • Analyze and report sales data, competitive market trends, and customer insights to guide product decisions and potential style pricing strategies that align with company margin and sales targets, • Validate piercing ramp style compliance by reviewing studio ramp photos with each new roll out, • Monitor inventory levels and coordinate restocks, seasonal updates, and new product launches., • Inform studio operations, marketing and creative teams about delivery timing for both new deliveries and key replenishment, keeping the teams updated to any changes to assortment strategy or deliveries on a weekly basis, • Analyze ramp selling thru DOMO reporting and report out on performance monthly, • Analyze customer buying behavior and sales trends leveraging DOMO reporting to help inform product selection and purchasing strategy, • Plan and execute customer feedback sessions / with appropriate customers for new products - report on these efforts to help inform best options in order to hit sell through targets and improve jewelry percentage to topline, • Build and maintain strong relationships with jewelry vendors and piercing suppliers, and negotiate costing and delivery timing, • Work with closely with vendors on translating inspiration decks into assortments either thru vendor line sheets or thru development and approval of CAD’s, • Track and maintain spending within sample budget, • Maintain accurate tracking of all product samples, ensuring timely check-in and that the sample closet remains organized, well-maintained, and easily accessible at all times., • Support the sourcing for new vendors to cast a wider net on suppliers, • Gain a deep understanding of our customer—not just general trends, but the specific styles and preferences of those we serve—by working directly in our studios, hosting customer focus groups, and analyzing insights from our marketing CRM data.Trend & Market Research, • Stay at the forefront of jewelry and ear piercing trends, scouting emerging designers, and monitoring competitor assortments online and in stores., • Provide insights and recommendations to inform future collections and exclusives., • Stay ahead of jewelry and piercing trends by researching fashion forecasts, visiting Rowan studios monthly to elicit customer feedback on assortment and opportunities, competitive shopping once a quarter to ensure Rowan continues to take market share., • Work closely with marketing and visual merchandising teams to support product campaigns and in-store/online displays. Driving the product used in marketing campaigns., • Ensure all piercing jewelry meets safety, material, and regulatory standards (e.g., hypoallergenic metals, ASTM, or FDA compliance)., • Track KPIs such as sell-through rate, margin, and stock turnover to drive performance and make data-informed decisions., • Prepare buying reports and presentations for internal stakeholders., • Prepare PK knowledge decks and videos for Studios teams for each new collection launch, • Prepare executive presentations and decks for the CEO and other leadership team members on product strategies inclusive of but not limited to classification,age demographics, metal types and vendor roadmapWhat You Offer:, • Bachelor’s degree in Fashion Merchandising, Business, or a related field., • 2+ years of experience in retail buying, ideally in fashion accessories, jewelry, or piercing-related products., • Strong knowledge of jewelry materials (e.g., gold, titanium, stainless steel) and piercing industry standards., • Strong negotiation and vendor management skills., • Highly organized with strong analytical and Excel skills., • Passion for fashion trends and jewelry design., • Strong organizational and multitasking abilities., • Knowledge of health and safety regulations, particularly related to piercing, is a plus., • Excellent verbal and written communication skills., • Proficient working in Google Suite (Calendar, Gmail, Sheets, and Documents)., • Analytical skills, including basic retail math,calculating margin, inventory on-hand, tracking sales., • Experience working with global jewelry suppliers or independent designers., • Knowledge of ethical sourcing practices and sustainable materials., • Familiarity with POS and inventory management systems (e.g., Shopify, NetSuite,Domo).Full-Time Benefit + Perks:, • Medical/Dental/Vision Health Plans, • Long-term Disability, • Life Insurance, • 401k and Roth IRA Plans, • Paid Parental Leave, • Open PTO policy

Job Description Position hours: Monday-Friday, from 9 AM-5 PM. Lorenc Aesthetic Plastic Surgery Center is looking for a driven, goal-oriented, type-A player for a LPN / Research Assistant position to work in a private upscale cosmetic plastic surgery office Preforming LPN duties as well as assist our Study coordinator in our FDA Clinical trials. Job Details The job consists of assisting the doctor (plastic surgeon) to see patients during office hours, coordinating all surgical procedures, circulating in the OR, drawing blood and taking specimen samples as well as assisting the Study coordinator and taking delegation on FDA Study specific tasks. Candidate will also be operating our IV program which will require IV insertion and care. Certifications: The candidate will need a current LPN certification in addition to an IV certification. The ideal candidate has superb clinical and organizational skills. This is a front of the house position. Well groomed hair and clean manicure is required with a professional, polished, and friendly demeanor. This individual must have the ability to work independently with a proactive approach for time management and circulation of office tasks. Candidate MUST BE able to incorporate into a small intimate team and work as a team player with the willingness and ability to begin work as early as 8:30 and have the fexability to work past 5 PM when the occasion arises due to late patient care or surgeries. You must be available to work a MONDAY -FRIDAY 9-5 SHIFT. All candidates must have experience in Plastic/Cosmetic Surgery. Applicant should have experience with both front desk and back-office duties. WHAT YOU WILL DO: • Assist physician with patient examinations and office procedures (suture removal, set-up for minor surgeries, etc.), • Clean examination rooms, • Ensure examination rooms are fully stocked, take inventory assure all materials are available in advance, • Sterilize equipment, • Record patient and testing information, • Manage patient flow, • Dressing changes, • Logging specimens, • Laser/Micro-needling procedures, • Draw blood, • Answer phone calls, • Schedule and coordinate surgical appointments, • Work with the study coordinator to log subject information for FDA trails, • Use photo equipment particular to FDA trails to phot subjects progress in trails and log necessary updates, • take blood and specimen requirements for FDA Studies Pay: $65,000-$75,000 Expected hours: No less than 40 per week Company DescriptionZ. Paul Lorenc, MD, FACS (pronounced Lawrence), is a world-renowned board-certified aesthetic plastic surgeon who balances surgical expertise with an acute aesthetic sense of composition and proportion in the areas of facial rejuvenation, breast enhancement, and body contouring. After finishing medical school, Dr. Lorenc secured a position at the premier Surgical Residency Program at New York University Medical Center. Since establishing his private Park Avenue practice, Dr. Lorenc has been actively involved in research, development, and advancement of new aesthetic surgical and non-surgical techniques and procedures. He is internationally recognized for creating endoscopic techniques, most notably the endoscopic forehead lift, and holds numerous U.S. patents. As a recognized authority in facial anatomy, Dr. Lorenc is a pioneer in the development of the latest generation of dermal fillers and neurotoxins, leading various clinical trials for FDA approval in the U.S. Dr. Lorenc is often called upon to appear in front of the FDA in various capacities.Z. Paul Lorenc, MD, FACS (pronounced Lawrence), is a world-renowned board-certified aesthetic plastic surgeon who balances surgical expertise with an acute aesthetic sense of composition and proportion in the areas of facial rejuvenation, breast enhancement, and body contouring. After finishing medical school, Dr. Lorenc secured a position at the premier Surgical Residency Program at New York University Medical Center.\r\n\r\nSince establishing his private Park Avenue practice, Dr. Lorenc has been actively involved in research, development, and advancement of new aesthetic surgical and non-surgical techniques and procedures. He is internationally recognized for creating endoscopic techniques, most notably the endoscopic forehead lift, and holds numerous U.S. patents. As a recognized authority in facial anatomy, Dr. Lorenc is a pioneer in the development of the latest generation of dermal fillers and neurotoxins, leading various clinical trials for FDA approval in the U.S. Dr. Lorenc is often called upon to appear in front of the FDA in various capacities.

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 DescriptionDescription: Leading Freight Forwarder / NVOCC/ Customs House Broker/ Tank Container Operator, with locations in 24 countries and over 3300 employees strong, is seeking a highly motivated and organized individual to fill the position of Import Customer Service Representative – Customs Entry Writer in our Jersey City, NJ office. Responsibilities include but are not limited to: • Preparing and submitting customs entries: This involves preparing the necessary documentation and data to US Customs and Border Protection (CBP) and other government agencies like the FDA, Fish & Wildlife Service (FWS), USDA, etc., • Transmission of Customs Entries to U.S. Customs for import shipments, • Ensuring compliance: Verify accuracy of documents (commercial invoices, etc.) and ensure compliance with US Customs regulations., • Coordinating with various parties: Communicate and coordinate with internal / external customers, carriers, freight forwarders, customs officials and other agencies to ensure smooth clearance of good, • Problem-solving: Resolve documentation discrepancies, Customs exams, FDA holds, or other issues related to Customs clearance., • Receiving, reviewing, and processing import documentation for an assigned base of accounts, • Preparing daily activities including: preparing delivery orders and coordinating the pickup and delivery of cargo, filing ISF (Importer Security Filing), answering emails, • Processing documents through the system and interface and providing updates and communications for internal and external customers to produce timely and compliant transactions, • Tracing key transaction information such as HBL, commercial invoice, and other required documents to determine if record is available, • Corresponding with overseas agents and clients, • Working with steamship lines/airlines/trucking companies to obtain quotations and handle the movement of freight, • Developing and maintaining excellent customer service to internal and external customers, • Preparing quotations, • Handling the files from A to Z, • Responsible to ensure legal compliance, provide import guidance and control within government rules and regulations. Requirements: Job Requirements: · Minimum 2- 4 years of experience in Import Customs Clearance operations · Knowledge of current and historical Customs regulations, Harmonized Tariff Schedule, and related directives of government agencies (including but not limited to Environmental Protection Agency (EPA), Food and Drug Administration (FDA) and United States Agriculture Department (USDA) is a plus) · Be able to work independently, multi-task, be a team player and work in a fast-paced environment · Possess excellent written and verbal communication skills · Have computer skills and knowledge of Microsoft Outlook, Excel, Word and Access · Experience with the handling of hazardous materials a plus Our Benefits include: · Medical · Dental · Vision · Flexible Spending Account (Medical and Dependent Care) · 401(k) with company match · Company paid Life Insurance, Short-Term Disability and Long-Term Disability · Paid Holidays plus PTO and Sick Leave · Voluntary Time Off · Employee Assistance Program · Tuition Reimbursement · Employee Referral Program · Employee Discounts When applying, the candidate should include salary requirement. Background check required. Only those considered for the position will be contacted. Thank you for your interest.

Job DescriptionThis position will report into the Manager of QC Analytical. The QC Analytical Supervisor will organize, and direct staff to meet and exceed cGMP requirements, and establish KPI’s, while adhering to quality control and technical standards. The QC Analytical Supervisor will also provide oversight of day to day activities including adjustment of workflow, test performance, and quality compliance. • Ensures compliance with regulatory agency requirements by enforcing a quality culture throughout the department., • Schedules and monitors daily operation of department based on projected client demands., • Conducts routine walkthroughs of the facility to ensure compliance with regulatory and quality practices., • Approval of investigations and documentation of non-confirming events and OOS., • Recommends process improvements to achieve greater efficiency within the department and between sites., • Participates in department and cross functional meetings., • Maintains audit readiness within the department by ensuring proper training of staff, reviewing documentation, and ensuring laboratory cleanliness., • Interacts with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns., • Direct reports: QC Analysts (Approximately 8-10 reports), • Other duties as assigned.REQUIREMENTS, • BS degree in Science or relevant field;, • 7+ years of experience with analytical laboratory or within the biopharmaceutical industry or equivalent., • Strong knowledge of FDA and EU regulatory standards. cGMP experience required., • Strong knowledge of analytical test methods and philosophies., • Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review., • Proficient with computer software with MS Office and LIMS, • Competencies/Candidate Profile, • Acts decisively, • Exercises good judgment and makes effective, sound, timely and informed decisions. Seeks to identify, analyze and resolve problems effectively., • Builds and maintains relationships, • Strong collaborative and influencing skills and ability to work well in a matrixed environment with internal and external stakeholders., • Communicates effectively, • Uses appropriate modes and media, targeting the amount, level of detail, and content of the information to the needs of the audience. Prepares clear, concise, and well-organized written documents and oral presentations. Conveys information clearly, confidently, and with the proper tone. Facilitates open communication. Uses discretion and demonstrates sensitivity to confidentiality concerns. Listens effectively and provides appropriate feedback., • Fosters continuous improvement and innovation, • Promotes efforts aimed at improving current business processes through a culture that fosters continuous improvement and innovation. Identifies and implements improvements and innovations that increase efficiency and enhance work quality. Promotes ongoing development of staff and takes initiative to assess and self-develop supervisory competencies., • Fosters integrity and honesty, • Displays and fosters integrity and honesty through the promotion of mutual trust and respect, demonstrates and fosters high ethical standards, and treats others fairly and ethically., • Supervises and manages performance, • Builds and manages a multi-sector workforce based on organizational goals, budget considerations, and staffing needs. Ensures staff are recruited and selected using merit principles. Ensures tasks are appropriately delegated and completed by monitoring performance against predetermined standards and requirements and holding staff accountable for meeting expectations. Trains and develops staff, provides constructive performance feedback and appraisals, and takes appropriate corrective action to address performance and conduct issues., • Manages projects and functions, • Manages projects and leads initiatives in the workplace. Organizes resources, people, and activities; and ensures collaboration and the achievement of project and function goals and targets. Ensures effectiveness and efficiency in the delivery of services, products and/or programs., • Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees., • Provides oversight and direction to the employees in accordance with the organization's policies and procedures., • Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities., • Empowers employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback., • Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise., • Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization., • Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning., • Appropriately communicates organization information through department meetings, one-on-one meetings, appropriate email, and regular interpersonal communication., • GxP/GDP TrainingWorking EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. Must have the ability to work with specialized equipment.The employee must be able to comply with the company's personal hygiene standards as they apply to aseptic processing. The employee must successfully complete sterile gowning training/qualification as well as annual re-qualification as a core competency requirement of their employment in this role. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Overview: The Strategic Account Manager is primarily responsible for Resident/Fellow education, training, certification, and handoff continuum activities and, secondarily, for the ongoing sales and support of the Company's product(s) in the US Ophthalmology Teaching Institutions, Veteran Affairs Hospitals, and Department of Defense Hospitals. Responsibilities: • Create demand for Sight Sciences products within both company and industry-compliant guidelines, • Develop effective educational and sales presentations to differentiate product(s) compared to current surgical glaucoma offerings with Ophthalmic surgeons within the assigned territory, • Analyze data and manage territory to create an effective business plan, including regular funnel management and forecasting, • Maintain knowledge of current trends in the industry and competitive products, • Manage territory budget and resources, • Complete administrative paperwork in a timely manner and communicate with the Manager regarding established key performance indicators and feedback from physicians., • Attend various sales training workshops, sales meetings, national/regional conferences, and relevant trade shows, • Maintains direct contact with customers to enable the best clinical outcomes, • Establish and foster Key Opinion Leader (KOL) and Future Key Opinion Leader (FOL) relationships, • Pre-sale: Responds to customer inquiries to determine appropriate product literature and pricing schedules; influences production and shipping schedules, • Post-sale: Responds to customer inquiries (RMA, status, delivery, etc.). Resolves production scheduling and shipping or invoicing problems; determines the validity of warranty claims and schedules repair resources, • Support company goals and objectives, policies, and procedures that comply with FDA Quality System Regulations (QSR), ISO 13485, and any other applicable domestic or international requirements, • Maintain a professional and credible image with key physicians, distributors, consultants, vendors, and co-workers Skills/Qualifications: • Bachelor's degree or equivalent experience required, • 5+ years of sales experience, with preferably a minimum of 3 years of medical sales experience in ophthalmology, with a proven track record of success, • Successful sales track record in the medical device industry, • Ability to navigate complex health systems efficiently, • Strong relationship-building skills, • Strong sales presentation skills, • Ability to work independently and as well as within a strong team environment, • Excellent verbal and written communication and presentation skills necessary, • Strong business acumen skills, • Required residence in territory geography, • Travel requirement: 30% to 60% overnight travel (territory dependent), • Face-to-face interaction with customers: 90% #LI-Hybrid For California, the base salary range for this position is $145,000 - $165,000 (highly qualified) a year. The Company maintains highly competitive, performance-based compensation programs.

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 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: Our Director, Product Communications leads the development and execution of communications strategies for our pipeline and future assets. This role is pivotal in shaping the narrative around our scientific innovation and rigour, managing reputation through clinical milestones, and preparing the external environment for a potential first-in-class commercial launch. The role partners with Commercial, Medical Affairs, Investor Relations, Patient Advocacy and others, to deliver consistent, compliant, and impactful messaging across earned, owned, and shared channels, ensuring our mission resonates with patients, providers, and payers. Location: Hybrid in our New York City office or remote on the east coast in the United States. Reports to: Vice President, Communications. Roles and responsibilities (Include but are not limited to): Strategic Product Communications • Lead the development and implementation of comprehensive product communication strategies to support our investigational product through Phase 3 data readouts, regulatory filings, and potential commercial launch, • Design and execute global communications programs that articulate the scientific and clinical value of our pipeline to media, HCPs, and patient communities, ensuring alignment with Compass's corporate narrative, • Partner with cross-functional teams including Commercial, Medical Affairs, Regulatory, and Legal to ensure all communications are compliant, accurate, and strategically aligned with business objectives, • Establish and manage relationships with key trade, healthcare and consumer journalists, • Develop high-impact materials including press releases, Q&As, key message documents, for clinical milestones and congresses, • Build and execute communications plans for launch readiness, creating disease state awareness campaigns in partnership with cross-functional team members that reduce stigma and educate stakeholders on treatment-resistant depression (TRD) and PTSD, • Collaborate with the Medical Affairs and Scientific Communications teams to amplify data dissemination at major medical congresses and through peer-reviewed publications, • Over 10 years of experience in pharmaceutical/biotech communications or public relations; agency and in-house experience preferred, • Proven track record leading product communications for a product launch, ideally as a first-in-class; CNS/psychiatry preferred, • Deep understanding of FDA/EMA regulations regarding drug promotion and scientific exchange, • Expertise in media relations with established contacts in biotech, healthcare and consumer sectors, • Proven track record of being an out-of-the-box and highly creative thinker, adept at building unique plans that reach stakeholders in new and different ways, • Cross-functional collaborator with excellent communication skills, able to navigate a matrixed environment across Commercial, Medical, and IR, • Adept at managing external public relations agencies and vendors, ensuring budget efficiency and high-quality execution of tactical plans, • Hands-on builder capable of setting strategy while executing tactical deliverables in a fast-paced, growth-stage environment, • Degree in Communications or Journalism; advanced degree preferred, • Mission-aligned, inclusive leader reflecting Compass's wellbeing-first, stigma free culture Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$190,000—$240,000 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: 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 DescriptionABOUT PROJECT HEALTHY MINDS Project Healthy Minds is a mental health tech non-profit startup. We are pioneering a first-of-its-kind model: applying technology to address one of the biggest social issues of our time: the growing mental health crisis. We believe in a simple but profound idea: that it should be as easy to find mental health services as it is to book a flight or a restaurant reservation. That's why we're building the world’s first digital marketplace for finding mental health services that are right for you. To do that, we work with some of the most inspiring and influential leaders in America - business titans, tech entrepreneurs, clinicians and scientists, musicians, artists, athletes, media stars, policymakers, and more - because we believe that the world's most complex challenges require interdisciplinary teams and solutions. We are backed by a powerhouse of industry-leading Board of Directors and Advisory Council Members who are passionate, hands-on, and dive into the important work with us. Learn more at projecthealthyminds.com and @projecthealthyminds on social. ABOUT THE ROLE WHAT WE’RE LOOKING FOR: Creating best-in-class donor data systems is integral to supporting Project Healthy Minds’ mission. The Development Operations Associate will be a key contributor responsible for developing and continuously improving all fundraising operations. This candidate will provide ongoing administrative support and Salesforce expertise that lead to analytically-driven and strategic operational outcomes. Additionally, they will manage all individual funders who give less than $5K, gaining front-end development experience through donor stewardship and cultivation efforts. We’re looking for a self-starter who is eager to focus on setting a high standard for gift administration, information management, data automation, and reporting throughout the development process. HOW YOU’LL CONTRIBUTE:• As the lead creator and driver for all gift processing systems, execute daily gift entry and acknowledgement letters.• Update and manage gift acknowledgement letters and recognition plans with the Development team.• Manage relationships with funders giving less than $5K, including donor stewardship, cultivation, and communications. • Lead large fundraising campaigns such as the spring appeal, fall appeal, and Giving Tuesday to creatively engage small funders and nurture them into long-term champions.• Research donor biographical information, keeping all donor records up-to-date.• Advise on tech stack and integrate data from third-party platforms into Salesforce.• Develop and maintain a dynamic donor segmentation system within Salesforce, tailored to identify and categorize major gift prospects based on giving history, engagement levels, and potential capacity to streamline targeted fundraising initiatives and personalized donor strategies.• Initiate and manage a continuous improvement program for fundraising technologies and platforms, ensuring they remain cutting-edge and effectively meet the organization's and its donors' evolving needs.• Provide regular donor reports to the team, from at-a-glance summaries to robust analyses, converting data into key decisions. • Create dashboards to capture and maintain all events and communications in Salesforce.• Partner with the Development & Events teams to create event registration, check-in, and gratitude procedures. • Create and maintain documentation for all Development Operations processes and protocols.• Act as a liaison with the CFO to complete revenue reconciliation as needed and assist with annual external audits.• Provide excellent customer service to supporters via phone and email inquiries. • Collaborate on the coordination of new supporter cultivation and existing supporter stewardship.• Work closely with the CEO to capture donor meeting notes and action items.• Train all team members on application use. • Play a key role in the donor stewardship plan, ensuring donors and prospects are communicated with regularly. • Support all other day-to-day operations that enable a successful fundraising strategy. ABOUT YOU OUR IDEAL CANDIDATE IS:• Mission-driven – You are passionate about our work and eager to build something brand new in the mental health non-profit space.• Data-driven – You are analytical and metrics-driven. You might even say you’re obsessed with analyzing, interpreting, and leveraging complex data sets to scale impactful solutions. • Detail-oriented – When it comes to your work, you are hyper-organized with a keen attention to detail. • Proficient in Salesforce and Excel – Your past work experience has included building cross-functional donor data processes. • Collaborative – No task is too big or too small. You thrive in an entrepreneurial, fast-paced environment and know when to take ownership and when to ask for help.• A lifetime learner – You identify as a critical thinker and deep listener. You’re eager to ask questions and apply learnings skillfully.• Adaptable – You are highly comfortable in a changing environment.• A strong communicator – Building relationships is one of your core competencies. You care about delivering top-notch customer service, demonstrating that you care about resolving all stakeholder’s data needs. • Experienced – Bachelor’s degree and at least 2-4 years of experience preferred. WHAT WE OFFER

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 Director, Site of Care Marketing will be a critical and highly visible leader within the US Commercial team, responsible for developing and executing strategies to activate and expand sites of care, improve speed to therapy, and coordinate the complex care pathway between interventional psychiatry and other disciplines. This position is responsible for establishing strategic direction through analysis of insights to drive key strategic choices and support a historic launch for COMP360 in patients who have failed treatment with at least two antidepressants (ADs). This role focuses primarily on HCP and site‑of‑care experience initiatives, while also requiring the ability to collaborate on and lead projects that support the intersection between prescribing HCPs, care teams, patients, and families. Location: Hybrid in our New York City office or remote on the east coast in the United States. Reports to: Chief Commercial Officer. Roles and responsibilities (Include but are not limited to): Site of Care Strategy & Leadership • Lead and set the direction for strategies to support site of care excellence, education, infrastructure, operations, and key solutions to coordinate care, • Manage overarching strategic relationships internally and externally, including 3rd‑party service and solution partners, in the development and execution of market strategies, • Set strategic direction and execution guidance for customer‑facing teams as they engage sites of care to address barriers to treatment, • Manage complex and innovative projects, establishing vision and direction within a fast‑moving, challenging, and dynamic commercial environment, • Lead the creation of innovative strategic plans while driving execution of complex product growth opportunities and delivering measurable results, • Develop and execute Site of Care marketing strategy and tools in alignment with overall brand strategy and objectives, • Collaborate with Sales Operations to identify referral pathways and sites of care for potential treatment of patients with COMP360, • Lead a team of Health System Account Managers (and dotted line oversight of Thought Leader Liaisons) to negotiate with health systems and clinics, remove barriers to care, establish protocols and care pathways, and develop tools tailored to different site‑of‑care archetypes, • Partner with Patient Engagement to identify priority sites of care and referral pathways, and build targeted programs that address their needs, • Collaborate with Sales, Marketing, Access, Patient Engagement, and other matrix partners to prioritize mission‑critical marketing strategies, • Address marketing bottlenecks and complex treatment processes across diverse sites of care, • 10+ years of experience in the biotechnology or pharmaceutical industry, with exposure to site‑of‑care strategy, HCP engagement, commercial execution, or market development, • Strong understanding of care delivery models, referral pathways, and operational barriers that influence speed to therapy, • Demonstrated ability to lead cross‑functional initiatives and collaborate effectively with Sales, Market Access, Medical Affairs, and Patient Engagement, • Experience managing complex, high‑impact projects in dynamic commercial environments, balancing strategy with hands‑on execution, • Skilled in building productive relationships with health systems, clinics, and external solution partners, • Strong analytical and problem‑solving skills, with the ability to turn insights into clear strategic recommendations, • Excellent communication and influence capabilities, with the ability to guide customer‑facing teams and align stakeholders, • Adaptable, organized, and comfortable operating in fast‑changing, ambiguous environments Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$250,000—$330,000 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: 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 DescriptionAbout Project Healthy Minds Project Healthy Minds is a mental health nonprofit that runs like a tech startup. We are pioneering a first-of-its-kind model: applying technology to address one of the biggest social issues of our time: the growing mental health crisis. We believe in a simple but profound idea: that it should be as easy to find mental health services as it is to book a flight or a restaurant reservation. That's why we're building the world’s first digital marketplace for finding mental health services that are right for you. To do that, we work with some of the most inspiring and influential leaders in America - business titans, tech entrepreneurs, clinicians and scientists, musicians, artists, athletes, media stars, policymakers, and more - because we believe that the world's most complex challenges require interdisciplinary teams and solutions. We are backed by a powerhouse of industry-leading Board of Directors and Advisory Council Members who are passionate, hands-on, and dive into the important work with us. Learn more at projecthealthyminds.com and @projecthealthyminds on social. About The Role WHAT WE'RE LOOKING FOR The Principal Engineer is a core member of the product development team at Project Healthy Minds, responsible for designing and building the technical foundations of a data-intensive mental health services marketplace. This role exists to ensure we can reliably ingest, normalize, and power complex service data—enabling product experiences that help millions of people find mental health support that actually works. This is a full-time, in-office position. HOW YOU'LL CONTRIBUTE

Job Description Robert Half is seeking a highly skilled Healthcare Procurement Counsel with deep expertise in healthcare, technology, and complex commercial contracting. In this role, you will drive enterprise-wide procurement strategy and serve as a trusted legal advisor to both operational leadership and the broader legal team. This role is ideal for an attorney who thrives in fast-paced, collaborative environments and has hands-on experience negotiating sophisticated technology, data, clinical, and vendor agreements — particularly within healthcare systems, health plans, research organizations, or public-private partnerships. Location: New York, NY (Downtown/Tribeca) Schedule: Hybrid — 4 Days Onsite (Mon–Thurs), Remote on Fridays Duration: 6+ Months (Potential Extension) Compensation: $85+/hour Why This Role Stands Out You will be at the center of the organization’s most important procurements, working across IT, clinical operations, pharmacy, supply chain, medical devices, and digital health to ensure compliant, efficient, and strategically aligned contracting. This is a highly visible position that blends procurement, regulatory, technology, and healthcare operations. Key Responsibilities Strategic Legal Support • Provide expert legal counsel on procurement matters including vendor agreements, IT and SaaS contracts, clinical and operational procurements, and supply chain transactions., • Draft, review, and negotiate a wide variety of procurement agreements, such as:, • SaaS and cloud-based technology contracts, • Cybersecurity and data‑sharing agreements, • Professional services and consulting agreements, • Clinical and medical technology procurements, • Identify and mitigate legal and operational risks throughout the procurement lifecycle., • Support development, enhancement, and implementation of internal procurement policies and workflows., • Partner closely with internal teams—including IT, finance, clinical operations, pharmacy, and supply chain—to deliver clear, practical legal guidance., • Provide responsive, solutions-oriented support to senior leadership and stakeholders. Qualifications • Juris Doctor (JD) from an accredited law school., • Active NY State Bar license (required)., • 3–7 years of commercial contracting experience, ideally in healthcare, life sciences, or health IT., • Strong working knowledge of HIPAA, FDA, CMS, data privacy, and healthcare regulatory frameworks., • Proven success negotiating complex procurement and vendor agreements., • Ability to operate in a fast‑paced, collaborative, and stakeholder‑facing environment., • Experience in public sector or quasi-public procurement highly preferred., • Excellent written, verbal, and interpersonal communication skills., • Prior experience working in healthcare provider, health plan, nonprofit health system, or research institution environments., • Strong familiarity with SaaS/cloud technology agreements and data governance., • Understanding of value-based care, managed care models, or healthcare reimbursement structures.

Job DescriptionSr. Manager Quality Assurance Validation Computerization Systems The incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • Bachelor’s Degree in a Scientific or Engineering discipline, • 8 + years of computerized system experience with IT compliance/validation/qualification activities., • 8 + years of experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • 10% travel required., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Primary Responsibilities Senior Clinical Trial Manager is responsible for ensuring the quality of clinical trials and implementing and overseeing various projects. Senior Clinical Trial Manager collaborates with the designated CRO and vendors, as well as internal team across functions, and directs activities to execute and deliver the assigned studies. This role reports to the Director of Clinical Operations. Specific Duties, may include but not be limited to the following: • Acting as a primary liaison with the CRO/CROs on the assigned projects, including global multi-center trials., • Providing management and oversight for the CROs/vendors involved in the assigned projects ensuring on time and on budget delivery., • Partnering with other functions internally to achieve key milestones, optimize processes and achieve efficiencies., • Providing regular reporting on project metrics and serving as internal liaison at Immuneering, regarding all project related inquiries, presentations and updates, • Creating and implementing study-specific clinical monitoring tools and documents in collaboration with CRO/vendors and internal team., • Identifying and choosing/approving sites and coordinating site startup activities., • Supervising and having regular meetings with the CRO and other clinical vendors involved in the projects, • Reviewing the clinical trial agreements and budgets for the CRO, vendors and clinical sites, • Overseeing the CRO’s contact with the study sites, including ordering/providing supplies and investigational product, and site management., • Ensuring inspection readiness and that all study activities are conducted in compliance with the protocol and procedures, GCP, FDA/EMA/local regulations, guidelines and policies., • Escalating issues as needed to the Sr Director, Clinical Operations with the proposed action plan, • Participating in the development of SOPs, working guidelines, mentoring and educational activities EDUCATION • B.S. (or higher) degree in a Science or related field required, • Minimum 8 years of work experience for a pharmaceutical company or CRO, • Minimum of 8 years of work experience in PM/CTM (or equivalent) roles on Oncology projects, • Global multi-center trial experience is required, • Demonstrated application and working knowledge of global GxP regulations for pharmaceutical industry (i.e., Good Clinical Practices, Good Lab Practices, current Good Manufacturing Practices, 21 CFR Part 11 Electronic Records; Electronic Signatures, MHRA/EMA/FDA regulatory body inspections) TECHNICAL / SOFT SKILLS • Outstanding communication skills, both verbal and written, • Proficient with Microsoft Office Word, Excel, PowerPoint, MS Project, • Ability to work independently and prioritize duties, • Understanding of Electronic Data Capture (EDC) and other clinical systems, • Strong analytical and organization skills, • Self-motivated and self-directed Physical Demands/ Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to 10% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.