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A rapidly growing biotech is seeking an Associate Director Regulatory Affairs to drive global CTA submission strategies. This team is composed of world-class scientists and innovators who are leading the charge of integrating advanced imaging and AI technologies to revolutionize drug discovery. The Associate Director Regulatory Affairs will be responsible for leading the development and execution of regulatory strategies for ex-US CTA submissions. The ideal candidate will have a strong understanding of global regulatory requirements and guidelines to ensure compliance, manage submissions, foster cross-functional collaboration, and serve as a liaison with regulatory agencies. Key Responsibilities • Design and implement regulatory strategies for clinical trial applications (CTAs) outside the U.S., ensuring alignment with organizational goals and timelines., • Lead the preparation, review, and coordination of regulatory submission packages across multiple regions (EU, UK, LATAM, APAC, etc.), • Develop dossier content plans in collaboration with internal stakeholders., • Oversee the lifecycle management of international CTAs., • Provide strategic input and support to cross-functional teams in preparing responses to health authority inquiries., • Monitor and interpret evolving global regulatory requirements, guidelines, and industry standards., • Ensure all clinical trial activities comply with applicable international regulations, including EU-CTR (Regulation EU No 536/2014), ICH guidelines, and country-specific legislation., • Serve as the primary contact for regulatory authorities regarding submissions and follow-ups., • Ensure regulatory compliance with quality systems, including GCP and GDPR., • Identify potential regulatory risks and recommend mitigation strategies proactively. Qualifications • Bachelor's degree with 10+ years of relevant experience, or advanced degree with 8+ years in a scientific or regulatory discipline., • Hands on experience supporting multiple CTA filings, • Deep understanding of international regulatory frameworks and submission platforms (e.g., CTIS, IRIS)., • Experience with documentation required by global health authorities, including clinical and GMP-related materials., • Strong communication, negotiation, and project management capabilities., • Proven success in cross-functional collaboration and regulatory strategy execution., • Comfortable working in a dynamic, fast-paced environment., • Proficiency in digital tools including Veeva Vault, Microsoft Office Suite, and other regulatory systems.

EVERSANA has partnered with Mitsubishi Tanabe Pharma America, Inc. for this Direct Hire opportunity. Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Japan’s most respected - is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis (MS), diabetes mellitus (DM), amyotrophic lateral sclerosis (ALS), and is currently developing medicines in Neurology in Parkinson’s (PD), Spinal Cord Injury (SCI), and in high unmet areas in Immunology and Oncology. MTPA is rapidly expanding its operations across all functional areas. MTPA’s commitment to patients and their communities continues with a robust late-stage pipeline of investigational treatments for difficult-to-treat diseases and commercializing products with significant unmet medical needs in North American markets. In the United States, MTPA launched rare disease treatments including RADICAVA® (edaravone) injectables in 2017 and RADICAVA® (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, supply chain, and business development functions. MTPA is dedicated to improving the treatment environment for those with debilitating diseases, researching on real-world evidence, and creating hope for all facing illness. Job Description Direct Hire Opportunity! The Senior Director, Trade & Distribution, will build, lead, and manage the team while focusing on developing strategies to support the launch and lifecycle management of our leading Parkinson's and ALS therapies, as well as future products in the United States. The primary responsibility of the Senior Director Trade & Distribution is to develop and implement the distribution strategies across the specialty businesses. This includes specialty pharmacies, distributors and all channels that would support any present or future MTPA products. This person will have an intimate knowledge of the distribution systems from all aspects including durable medical equipment. The ideal candidate will possess strong leadership experience in managing teams that work both directly and indirectly with specialty vendors, coupled with exceptional analytical skills to identify operational gaps and implement effective solutions. Cross-functional collaboration with supply chain, marketing, sales, and customer-facing teams will be key to success in this role. Responsibilities • Provides overall leadership and direction for Trade Market Access strategy for Mitsubishi Tanabe Pharma US’ lead Parkinson and ALS products, • Evolve and innovate distribution network by aligning it with business needs, identifying growth opportunities, and addressing operational gaps to overcome challenges and drive access. Serves as the Distribution and Trade Strategy Team Leader, representing, • trade across all teams and driving key success factors to support long-term distribution strategies. Lead the development and execution in Federal Markets, including VA and Department of Defense to drive product access, distribution, and growth. Act as subject, • matter expert from a Market Access perspective for 340B program and other government programs., • Informs senior and corporate executives informed about changes and emerging issues in the broad, trade customer environments and subsequent implications for Mitsubishi Tanabe Pharma US, • Develops awareness of market and government policy changes in collaboration with legal and compliance and implications across key stakeholders to help inform/update commercial strategies, • Assists market access marketing agency (and other vendor relationships) to develop promotional programs, tactics and materials aligned with our distribution process, • Develops/maintains thorough understanding of dynamics driving various market access segments and channels and how distribution impacts each function, • Effectively manages budgets and project timelines including contract management, • Oversight in the negotiation, execution, and adherence to the Distribution Service Agreements (DSAs), Product Purchase Agreements, and other contract offerings as appropriate, • Develop account metrics against strategic, financial, and product access KPI’s, • Develops and monitors KPIs, continually assessing impact and execution of access services & offerings including feedback from service users and internal stakeholders, • Attends professional, provider programs, and patient conferences, and keeps up to date on innovation and recommends ways to improve business., • This is a home office based position. The expectation is to be in the office 3 days a week. Qualifications • Bachelor’s Degree Required, Masters preferred, • Must have 15 plus years within the pharmaceutical industry and 10 years’ experience in Distribution, Account Management or Aligned Market Access functions., • Experience with distribution for early-stage pipeline programs, • Experience in Federal Markets including VA, Department of Defense and 340B Program preferred., • Device/Drug combination strongly preferred, • Minimum 5 years of people management experience required, • Track record of closing complex negotiations within the specialty pharmacy arena, • Preferred experience includes:, • All aspects of distribution, • Launch and life cycle management for the distribution process, • Experience in Market Access marketing, • History of successful negotiations, • Broad based knowledge of the Pharma/Biotech industry, healthcare finance, and all forms of product distribution: DME, Orals, and Solutions, • Firm grasp of legal, regulatory and compliance issues in the healthcare space, • Analytical/strategic thinker with proven ability to:, • conduct situation analysis of the external distribution environment; synthesize relevant information to develop strategic plans, • understand the best pathway for distribution based on the product and its attributes, • conduct strategic gap analysis and implement metric-based solutions, • Strong interpersonal and internal/external relationship-building skills in order to drive change and innovation and succeed in a highly specialized distribution environment, • Excellent oral/written communication skills, coupled with exceptional presentation skills, including ability to present to large audiences, • Ability to prioritize and manage complex projects, with multiple stakeholders, and drive high-quality results within allotted budget, • Highly proficient in MS Office; advanced Excel skills Mitsubishi Tanabe Pharma America Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits. MTP provides a competitive benefits package inclusive of Medical and Dental health benefits, short-term and long-term disability plans, Company Paid and Supplemental Life insurance and additional voluntary benefits such as Critical Illness Insurance, Accident Insurance, Legal Plan, and ID Theft Protection. In addition, we provide a generous PTO policy based on tenure, commencing with 24 PTO days, pro-rated based on hire date.

Job DescriptionAbout MMS MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating. Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide. MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. For more information, visit or follow MMS on LinkedIn. This position requires proven Project Management experience in supporting marketing applications, as well as in the development and management of Risk Evaluation and Mitigation Strategies (REMS) programs. Responsibilities: • Understands various cost models and develops budgets for moderate complexity projects., • Ensures financial KPIs are achieved on assigned projects; invoices on-time and ensures alignment with the contracted payment schedule; updates revenue projections on assigned projects. Controls project scope via defined PM methodology and processes for change management., • Develops moderate complexity project timelines independently., • Performs advanced functions in MSP. Understands task constraints and conveys critical path milestones to the functional lead. Develops/input into strategies to help achieve timeline expectations., • Executes day-to-day activities during the course of a program/project including risk identification, issue escalation and resolution. Collaborates with functional line management to resolve any issues and trends., • Intermediate excel skills (Hlookup, Vlookup, Pivot Table, etc.)., • Drives customer satisfaction and works to strengthen client relationships. Develops an account growth plan and consults with line manager to achieve a 10% revenue growth annually (minimum). Manages minimum one key account., • Participates in or leads RFIs/RFPs in collaboration with proposals team. Participates in or leads capabilities meetings - at least 2 annually., • Participates in or leads bid defenses - at least 1 annually., • Proficient in Word, Outlook, PowerPoint., • Proficient in meeting facilitation including scheduling, development of agendas and meeting minutes; works with project leads to ensure meeting objectives are met., • Understands general requirements: ICH, 21CRF Part 11, and ISO 9001:2000.Responsibilities:, • Bachelor’s Degree required, or relevant work experience., • Minimum of 5 years’ experience in project coordination or project management or similar field required., • Expert knowledge of scientific principles and concepts., • Proficiency with MS Office applications., • Hands-on experience with clinical trial and pharmaceutical development preferred., • Good communication skills and willingness to work with others to clearly understand needs and solve problems., • Excellent problem-solving skills., • Good organizational and communication skills., • Familiarity with current ISO 9001 and ISO 27001 standards preferred., • Familiarity with 21 CFR Part 11, FDA, and GCP requirements. KqpqOtSfcs

Job DescriptionPrimary Job Title: Medical Laboratory ScientistAlternate/Related Job Titles: • Medical Technologist (MT), • Clinical Laboratory Scientist (CLS), • Medical Laboratory Technologist, • Position Type: Contract, • Contract Duration: 3.5 months (estimated), • Start: As Soon As Possible, • Follow all laboratory policies and procedures for specimen handling, analysis, reporting, and recordkeeping., • Maintain records demonstrating that proficiency testing samples are tested in the same manner as patient specimens., • Perform complex test analyses using approved methods and release validated results., • Adhere to quality control (QC) standards; document all QC activities, calibrations, and maintenance., • Identify and correct test performance issues, notifying supervisors of problems as necessary., • Maintain accurate documentation of all corrective actions when deviations occur., • Handle STAT and critical results according to laboratory protocol., • Maintain appearance and cleanliness of the laboratory work area., • Verify reagent/test kit details including received dates, expiration dates, and storage conditions., • Participate in safety training, departmental meetings, and regulatory inspections as required., • Collaborate with colleagues and other departments to ensure workflow efficiency and compliance., • Uphold patient confidentiality and demonstrate excellent customer service when interacting with clients.Required Experience:, • Minimum 1 year of clinical laboratory experience performing high-complexity testing., • Experience with laboratory information systems (LIS) and working across multiple computer platforms., • Knowledge of quality control (QC) and quality assurance (QA) best practices., • Proficiency in specimen processing and test result validation.Education & Certifications:, • BS in Medical Technology preferred; or BS/BA in Chemistry, Biology, or Associates degree in Laboratory Science or Medical Technology., • Eligibility for national certification as a Medical Technologist or Medical Laboratory Scientist (ASCP or AMT) preferred., • Candidates educated outside the U.S. must provide a credential evaluation from IERF (International Education Research Foundation)., • U.S.-educated candidates must provide original transcripts., • National and state licensure as required by law.Required Skills:, • Clinical Laboratory Testing, • Quality Control & Instrument Maintenance, • Data Accuracy & DocumentationPreferred Skills:, • Laboratory Information Systems (LIS), • CLIA, HIPAA & OSHA Compliance, • Specimen Handling & Troubleshooting, • Time Management & Prioritization, • Interdepartmental CommunicationAdditional Skills:, • Reagent Management & Inventory, • Training Participation & SOP Adherence, • Critical Results Reporting Benefits: * Medical, Vision, and Dental Insurance Plans * 401k Retirement Fund About the Client: A leading provider of diagnostic information services, empowering healthier lives through clinical testing and data insights. Leveraging the world’s largest laboratory database, the organization delivers innovative diagnostic solutions that help identify, treat, and prevent diseases while improving patient outcomes worldwide. About GTT: GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. As a Native American-owned, economically disadvantaged corporation, we highly value diverse and inclusive workplaces. Our clients are Fortune 500 banking, insurance, financial services, and technology companies, along with some of the nation’s largest life sciences, biotech, utility, and retail companies across the U.S. and Canada. We look forward to helping you land your next great career opportunity! Job Number: 25-27088 #gttqst #gttjobs Company DescriptionGlobal Technical Talent is a subsidiary of Chenega Corporation () with over 1.3 billion US$ in revenue and 5800 US employees. We provide Total Talent Solutions, Global staffing, SOW, RPO, Direct Sourcing, and Global Payroll with physical offices in US, Canada, and India. GTT Digital headquartered in Toronto specializes in providing high-tech digital and banking talent to some of the nation’s largest financial institutions. As a leader in the staffing industry for over 22 years, we have become one of the largest staffing firms in the New England region, working with Fortune 500 clients and cutting-edge, technology-driven recruiting infrastructure. We are a Native American-owned, economically disadvantaged corporation that highly values diverse and inclusive workplaces. Our clients and partners are among the most successful and innovative organizations in the world. Our top clients are Fortune 500 banking, insurance, and financial services firms, some of the nation’s largest life sciences, biotech, utility, and retail companies, and prestigious educational institutions in the Ivy League tier. There is always a new opportunity for success when you look through all of the open job opportunities on our website’s career page. Just click on this link: Awards SIA’s Fastest Growing Staffing Firm: 2023 and 2015 SIA’s Best Staffing Firm to Work for: 2019 -2023 Inc 5000 Fastest Growing Private Company: 2023, 2022, 2016, 2015 Randstad Preferred Supplier: 2020 - 2023 TechServe Alliance Excellence Award. 2019 NH Business Magazines Fast 5 fastest growing companies Ernst & Young Entrepreneur of the Year Finalist: 2015Global Technical Talent is a subsidiary of Chenega Corporation () with over 1.3 billion US$ in revenue and 5800 US employees. We provide Total Talent Solutions, Global staffing, SOW, RPO, Direct Sourcing, and Global Payroll with physical offices in US, Canada, and India. GTT Digital headquartered in Toronto specializes in providing high-tech digital and banking talent to some of the nation’s largest financial institutions. As a leader in the staffing industry for over 22 years, we have become one of the largest staffing firms in the New England region, working with Fortune 500 clients and cutting-edge, technology-driven recruiting infrastructure.\r\n\r\nWe are a Native American-owned, economically disadvantaged corporation that highly values diverse and inclusive workplaces. Our clients and partners are among the most successful and innovative organizations in the world. Our top clients are Fortune 500 banking, insurance, and financial services firms, some of the nation’s largest life sciences, biotech, utility, and retail companies, and prestigious educational institutions in the Ivy League tier.\r\n \r\nThere is always a new opportunity for success when you look through all of the open job opportunities on our website’s career page. Just click on this link: \r\n \r\nAwards\r\n\r\nSIA’s Fastest Growing Staffing Firm: 2023 and 2015\r\nSIA’s Best Staffing Firm to Work for: 2019 -2023\r\nInc 5000 Fastest Growing Private Company: 2023, 2022, 2016, 2015\r\nRandstad Preferred Supplier: 2020 - 2023\r\nTechServe Alliance Excellence Award. 2019\r\nNH Business Magazines Fast 5 fastest growing companies\r\nErnst & Young Entrepreneur of the Year Finalist: 2015

Job Description NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We're exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. Japan. Job Summary: Responsible for the management and execution of various aspects of translational and early-stage clinical studies (implementation, site selection, patient recruitment, vendor selection and oversight, tracking clinical data, etc.) for global clinical studies with adherence to all relevant regulations including FDA, ICH and Regulatory requirements. This is a hybrid position that requires to be in the Paramus office twice a week. Essential Duties and Responsibilities: • Develop and deliver program level translational and early-stage clinical drug development strategy, • Design, plan and execute biomarker strategies to inform indication priorities, commercial differentiation, regulatory strategies, biomarker qualification plan, and that achieve biomarker-driven milestones, such as target engagement, measurement assay development and validation, pharmacodynamic activity, and other biomarker contexts of use in clinical-stage programs, • Integrate with colleagues in discovery research and research-stage project teams to identify translational biomarkers and demonstrate preclinical target engagement, methodology of detection and measurement, proof-of-mechanism, pharmacodynamic activity, PK/PD relationships., • Plan, implement, manage and report for regional or global clinical studies., • Manage and Lead selection process of CROs for regional or global clinical studies., • Direct, oversight and manage the performance of study vendors (e.g. CROs and central labs)., • Provide direction and guidance with the Clinical Lead to achieve project objectives., • Manage and resolve project performance issues (issue management) if they arise., • Manage activities for clinical site selection, investigator meetings and study initiation., • Oversight of patient recruitment and development of recruitment strategies and plans., • Responsible for the creation of study related documentation (protocol, ICF, CRF, operations manuals etc.)., • Tracking clinical data, regulatory documents, and patient enrollment information and data resolutions to assure the timely completion of clinical studies in line with approved clinical development plans., • Assure compliance of investigational sites with SOPs, FDA regulations and ICH guidelines to assure that the studies are carried out fulfilling the requirements of the study protocols., • Manage negotiation of clinical trial contracts between investigational sites and CROs., • Oversight of data management vendors and statistical analysis vendors to ensure timely analysis output delivery in accordance with Statistical Analysis Plan., • Responsible for coordination with clinical suppliers to ensure appropriate and timely delivery of clinical trial supplies to clinical sites., • Implement project specific training program and training materials, • Create and maintain clinical SOPs and TMF as part of global QMS and TMF processes., • Must be able to work effectively in a multi-cultural, global team environment as responsibilities include intensive drug development collaboration with global project teams, NS Pharma Japan (HQ), external partners and vendors., • Experience in negotiating Master Service Agreements, Project Specific Contracts and Budgets., • Good cross-functional team leader who fosters team spirit and team motivation (teamwork), • Thorough understanding of clinical operations involved as related to the planning, launching, and closing clinical studies., • Ability to anticipate and timely escalate issues and to define appropriate action plans, • Decision-making and problem-solving skills, • Ability to handle multiple tasks and prioritize, • Strong organizational, communication and presentation skills, • PhD and/or MD with 8+ years of experience in pharmaceutical or biotech R&D. MS or BS with 12+ years of R&D experience with progressive levels of team leadership also considered., • Preference for those with 5+ years’ experience as a Translational lead for clinical programs. Experience with Ph2/3 or registrational programs desired., • Excellent understanding of drug development, regulatory processes and clinical development NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job. The annualized target salary range for this role is $175,000 to $220, 000; actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit. Other benefits include: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs, • Discretionary Bonus Programs and Long-term Incentive Plan, • Retirement Savings 401k with company match, • Generous Paid Time Off, Sick Time & Paid Holidays including a paid Year-End Shutdown., • Career Development, Progression and Training NS Pharma is an EEO employer.

Job DescriptionCompany Description At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us! Across our growing organization, 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. We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA. Job Description The EVERSANA/Theratechnologies Field Reimbursement Manager (FRM) plays a critical role in minimizing access and reimbursement barriers for patients and healthcare providers to ensure timely access to the product portfolio. By addressing complex patient access challenges, the FRM serves as a trusted resource for private practices, multi-specialty groups, and facilities, supporting them throughout the reimbursement cycle. This role collaborates closely with Market Access, Patient Services, and Field Sales teams to ensure seamless patient drug accessibility and delivers compliant, patient-focused solutions to optimize access. ESSENTIAL DUTIES AND RESPONSIBILITIES: Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by: • Proactively address patient access barriers by working with customers and accounts to resolve complex reimbursement issues, including prior authorizations, appeals, and denials., • Educate private practices, multi-specialty groups, facilities, and their staff on reimbursement support programs, coverage, coding, and payer policies., • Partner with internal and external stakeholders to identify, anticipate, and address patient and practice reimbursement challenges., • Collaborate cross-functionally with Market Access, Patient Services, and Field Sales to provide compliant support for patients’ access to therapy., • Deliver clear and actionable information to practice managers, billing staff, nurses, and reimbursement teams to improve their understanding of payer policies and processes., • Provide real-time communication on payer policy updates and system changes that impact patient access in assigned accounts., • Conduct regular reviews with practices to understand their utilization of reimbursement support services and recommend program enhancements based on customer needs., • Handle patient health information (PHI) in accordance with HIPAA guidelines and company compliance policies., • Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias., • Maintain a deep understanding of policies, industry trends, and the legal and compliance aspects of reimbursement, applying this knowledge to all responsibilities., • Ensure a compliant relationship with state, local, and institutional societies while educating and supporting practices and accounts., • Share insights into customer needs, potential access barriers, and payer trends with internal teams to drive actionable improvements., • All other duties as assigned Qualifications MINIMUM KNOWLEDGE, SKILLS AND ABILITIES: The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required. • Education: Bachelor’s Degree, • Experience and/or Training:, • Proven experience in resolving complex patient access challenges, including prior authorizations, appeals, and denials., • Strong knowledge of the US healthcare system, reimbursement policies, and patient assistance programs., • Familiarity with the appropriate handling and use of PHI under HIPAA and other relevant legal frameworks., • Expertise in sales, sales management, marketing, training, market access, or account management, • Demonstrated ability to collaborate cross-functionally and manage stakeholder relationships effectively., • Ability to analyze customer insights and market dynamics to adapt strategies for patient access and support., • Ability to set goals and deliver agreed objectives under tight timelines, • Ability to prioritize, • Ability to generate ideas and find solutions, • Ability to work both alone and in a team, • Team spirit and tendency to help each other, • Versatility and flexibility, • Exceptional organizational skills, • Ability to assemble and lead cross-functional teams toward a shared vision of success 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 hold myself accountable. Embrace Diversity I create an environment of awareness and respect. 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. Always Innovate I am bold and creative in everything I do. Our team is aware of recent fraudulent job offers in the market, misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites, unsolicited e-mails, or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA. 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 DescriptionOur clients develops innovative clinical service products for cell therapy manufacture. They seek a Human Resources Representative Contractor for a 3-4 month contract role, reporting directly to the Sr. Director, Human Resources, operating in a matrixed environment, with responsibility to the business, multiple functions, internal customers, and vendors, the HR is the primary person who handles and provides support for various HR employee programs within the site. As an HR representative this role will support business leaders with staffing, training, HRIS, onboarding and process improvement initiatives. In addition, this role supports, implements, and executes all tactical aspects of the HR function at the site. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • Benefits function/administration of BenefitSolver and assisting with Open Enrollment., • Calculates and provides staff with annual fringe benefit allowance; reviews enrollment forms for accuracy and coordinates enrollment with third-party administrator., • Ensures compliance with COBRA guidelines by preparing letters and other paperwork as directed; receives and records COBRA insurance premium payments., • Coordinates health, life and disability insurance enrollments and communicates with service providers concerning routine administration of programs., • Maintains personnel files in compliance with applicable legal requirements., • Keeps employee records up to date by processing employee status changes in timely fashion., • Maintains listing of approved positions along with assigned salary grade levels., • Processes personnel action forms and ensures proper approvals; disseminates approved forms., • Prepares new-hire paperwork., • Assists in hiring process by coordinating job posting on the website, reviewing resumes, and performing telephone interviews and reference checks., • Maintains the employee handbook with updated resolutions and other pertinent information, as needed., • Supports all site efforts around recruitment and retention, HR program administration, employee relations, performance management, policy interpretation and application. Is responsible for day-to-day delivery of HR services; respond to general employee questions related to benefits, company policies and procedures., • Acts as a single point of contact for the employees and managers in assigned locations -Allendale and at times through matrix management, will work with our location in California., • First point of contact for employee relations issues and will assess, gather information and refer to HRBP/Project Leader., • Successfully monitor the “pulse” of the site to ensure a high level of employee engagement., • Support heavy volume recruitment activities; coordinates with RPO provider & representative on all candidates scheduling, debriefing and offers with management. May maintain the internal careers page and referral program., • Conduct new employee’s orientation and process all on-boarding and integration into the organization. Assures all new hire administration is processed timely, including coordinating and verifying benefits enrollment information and I-9’s., • Cooordinate the offboarding process which may include conducting exit interviews and coordination of documents., • Coordinate workers compensation claims with vendor and employees while partnering with EHS as required., • Manages leave of absence administration through provider., • Support Hitachi’s Compliance Program and activities., • Performs other related duties as required and assigned., • Comfortable with manually intensive environment, • Comfortable with computer systems, preferably ADP and some staffing (lower level interviewing). Competencies:, • Communication, • Relationship Management, • Ethical Practice, • This is a true “roll-up-your-sleeves” role. Must action oriented and the ability to get things done in a fast, fluid environment., • High level of integrity, curiosity, strong discipline, and a high degree of accuracy., • Must have high ethical standards and know when to report and/or investigate matters of utmost importance with complete confidentiality., • Customer Focused and diligently seeks to refine what needs to get done through employee experiences.REQUIREMENTS, • Bachelor’s Degree with 5-7 years of experience. PHR/SPHR or SHRM CP/SCP certification desired., • Proficiency in core HR disciplines such as: employee relations, talent management, compensation and total rewards, performance management, training and development and diversity/affirmative action developed via progressively responsible HR roles., • Demonstrated experience in tactical human resources operations. Current and in-depth knowledge of federal, state and local laws., • Experience with ADP preferred., • Proficiency with Microsoft office suite., • Experience in biotech, pharma or the life sciences highly preferred. Experience working in small manufacturing operations highly desirable., • Measured success working in an extremely fast-paced, high-profile environment., • Creative, can-do attitude, high comfort-level delivering simple, tactical solutions to complex problems., • Ability to maintain confidentiality while handling sensitive information; strong problem-solving and analytical skills, excellent judgment and composure., • High attention to detail required with a focus on ensuring deadlines are met and accurate records are kept., • Strong interpersonal skills and a proven ability to work with confidence independently and cross-functionally across various departments; establish and maintain effective relationships with internal and external parties; handle multiple projects and competing priorities with frequent interruptions., • Excellent communication and presentation skills and a proven ability to establish positive relations both internal and external., • Demonstrate success in fostering diverse workplaces that enable all participants to contribute to their full potential in pursuit of company objectives.

Job Description We’re recruiting Infrastructure, DevOps, and Reliability Engineers for high-growth startups including AirGarage, Dyno Therapeutics, Codex Health, and Banquet Health. These roles focus on scaling cloud systems, ensuring reliability, and enabling teams to ship quickly and securely. Opportunities span industries from AI to biotech, giving you the chance to work on meaningful projects at the cutting edge.

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 EMPLOYMENT OPPORTUNITY WITH MARCHESINI GROUP USA Seeking an Experienced SALES Manager to generate and handle sales for our Pharmaceutical R&D and Laboratory Equipment line of packaging machinery. Who we are… Marchesini Group USA is a leading supplier of primary and secondary packaging solutions to the pharmaceutical, biotech, and cosmetic industries. Established in 1992, our 23,000-square-foot North American headquarters supports the USA, Canada, and parts of the Caribbean and is backed by 2,500 Marchesini staff members worldwide. Our modern facility is equipped and staffed to meet the ever-increasing demands of today’s sophisticated and quality-conscious packaging clients. In today’s high-tech global marketplace, you need the right people and a commitment to providing the highest level of innovation, craftsmanship, reliability, and service. Our years of collective experience are at the service of our clients every day. Every member of Marchesini Group USA is here to satisfy our clients’ packaging requirements in the most effective way possible. Our sales team comprehensively analyzes and defines the customer’s packaging requirements to translate technical challenges into effective, unique packaging solutions. By combining the most advanced technology with our knowledge and understanding of the pharmaceutical, cosmetic, and consumer products industries, we have made solving packaging challenges our specialty. All precision packaging machinery available through Marchesini Group USA has been manufactured to meet the highest level of quality certification using established production benchmarks and testing procedures. No single element of our business is as important to our reputation and our success as quality…and it has never been compromised. About the position… RESPONSIBILITIES AND ESSENTIAL FUNCTIONS: • Develops, generates, and manages sales activity for Pharma R&D and Laboratory sector customers., • Manage and generate sales activity for large key accounts as well as small to mid-size customers., • Executes the complete sales cycle from initial contact onwards., • Creates and maintains strong working customer relations., • Maintains and manages the customer database and reports in CRM., • Sales forecast planning., • Drives growing sales in expanding market., • Provide timely and accurate reports as required. Pivotal Experience & Expertise Functional Experience: Brings strong commercial experience. Demonstrates an independent, results-driven work ethic. A self-starter and team player who is motivated to succeed. Superior people/customer relationship skills as well as strong interpersonal skills. Industry Experience & Tenure: 5 years’ broad experience and knowledge of pharma processes and packaging equipment. Brings strong network connections and relationships. Business Acumen: Understands business implications of decisions. Displays orientation to profitability. Demonstrates knowledge of market and competition. Aligns work with strategic goals. Competencies: • Adaptability: Adapts to changes in the work environment. Manages competing demands and changes approach or method to best fit the situation., • Collaboration and Teamwork: Balances team and individual responsibilities. Contributes to building a positive team spirit., • Customer Service: Focuses on serving customers as the organization’s top priority. Understands needs, creates distinctive value, and builds meaningful relationships. Aligns organization and resources to deliver on customer commitments. Driven to create value for customers., • Expert Communication: Excellent verbal and written communication skills. Responds promptly to customer needs to meet commitments., • Innovation: Displays original thinking and creativity and meets challenges with resourcefulness., • Learning: Curious, open-minded, and an avid listener who welcomes broad input, criticism, and feedback., • Motivation: Sets and achieves challenging goals. Demonstrates persistence and overcomes obstacles and measures self against the standard of excellence., • Planning/Organizing: Prioritizes and plans work activities while efficiently managing time., • Problem Solving: Identifies and resolves problems in a timely manner. Gathers and analyzes information skillfully and develops alternative solutions., • Strategic Thinking: Develops and implements strategic priorities to achieve organizational goals. Understands organization's strengths & weaknesses. Analyses the market and competition and identifies external threats and opportunities. Adapts strategy to changing conditions. Software Proficiencies: Microsoft O365, including Excel, Word, OneDrive, Outlook, PowerPoint, SharePoint, Teams. Benefits: The well-being of our employees and their families is our top priority. Therefore, Marchesini Group USA offers a generous and attractive benefits packaging including: Paid Time Off • Paid Holidays • Pension Plan • 401(k) Plan • Medical Insurance Dental Insurance • Vision Insurance • Short- and Long-Term Disability Insurance AD&D Insurance • Life Insurance • Employee Assistance Program • Optional Identity Theft Protection Coverage Work Status Eligibility and Requirements: Applicants must have a pre-existing legal US work status. Will not sponsor visas. Travel 60%+ Additional Language Knowledge: Not required but always a plus! ITALIAN/SPANISH LANGUAGE Salary: $67,000 annually + commission Powered by JazzHR ftlnyXuuzd

Job DescriptionQBench is the modern operating system for testing labs. We help scientific laboratories scale faster, reduce errors, and ship results seamlessly by replacing legacy systems with a highly configurable, cloud-native LIMS (Laboratory Information Management System). Our customers are doing everything from detecting food-borne pathogens to enabling cutting-edge molecular diagnostics — and we’re helping them do it faster and better. Why You’ll Love Working with Us: * Shape the Future of Lab Software: As a Product Designer at QBench, your work won’t just make our product look better — it will shape how scientists, technicians, and researchers work every day, helping them deliver faster, more accurate results that drive innovation. Career Growth: We’re committed to your professional development, offering continuous learning opportunities, mentorship, and the chance to lead strategic design initiatives. Collaborative Culture: Work with a tight-knit, cross-functional team that values curiosity, creativity, and your unique perspective. Your input will influence not only design but also product direction. Competitive Compensation: We offer a strong salary package and benefits designed to support your financial and personal well-being. Remote Flexibility: Enjoy the freedom of a fully remote role while still feeling connected to a motivated, mission-driven team. About the Role We’re looking for a talented Product Designer to join our growing product team and help shape the future of laboratory software. You’ll work closely with the product manager, engineers, and subject matter experts to research, design, and iterate on intuitive, elegant user experiences that solve complex problems for our customers. You’ll blend design craft with product thinking, and have ownership of features from concept to final polish, ensuring they are both delightful to use and highly functional. What You’ll Do * Conduct user research to deeply understand customer needs, workflows, pain points, and synthesize findings to guide design decisions. * Translate insights into end-to-end feature designs that align with both user goals and business priorities. * Translate concepts into user flows, wireframes, interactive prototypes, and high-fidelity mockups that lead to intuitive user experiences. * Collaborate with product and engineering to ensure designs are feasible, scalable, and implemented with high quality. * Take a user-centric design approach and iterate based on feedback and conduct usability testing to continually improve the product’s user experience. * Identify user experience challenges and design solutions that improve the overall UX for customers. * Make strategic design and user-experience decisions related to old and new features. * Advocate for design best practices and user needs while balancing technical and business constraints. * Contribute to our new and evolving design system. What We’re Looking For * 3-5 years of experience designing SaaS products, ideally in complex or technical domains. * A strong portfolio showcasing visual design excellence, and UI/UX and product thinking. * Proficiency in Figma and modern design practices. * Experience working from problem definition through to shipped product. * Strong understanding of user-centered design principles, accessibility, and responsive design. * Experience designing workflow software and dashboards. * Excellent communication skills and ability to work cross-functionally. * Demonstrated ability to collaborate in a remote-first environment. * Able to work within US-based time zones. Nice to Have * Experience designing for enterprise or B2B software. * Familiarity with laboratory workflows or LIMS platforms. * Experience designing compact applications that are highly configurable for power users. * Experience in regulated domains (e.g. HealthTech, Biotech, Life Sciences) Powered by JazzHR KMwmYSpQWh

Job DescriptionJob Title: GCP Sr. Auditor Work Location: Paramus, NJ Contract Type: W2 Only Work Type: Hybrid (3 days/week at Office) Travel Required: Upto ~10% site travel Work Authorization: Only GC / US Citizens About the Role: As the GCP Quality Assurance Senior Auditor, you will play a critical role in ensuring compliance with global GxP regulations, managing audits across clinical, nonclinical, and pharmacovigilance (PV) domains, and supporting high-integrity quality systems. You will report to the Director of GCP/PV Quality Assurance and will partner closely with clinical operations, vendor management, and cross-functional QA teams. Key Responsibilities: • Plan and lead internal and external GxP audits (clinical trials, vendor/CRO audits, investigator sites, CMOs, etc.), • Conduct risk-based audits of clinical processes and vendor systems (e.g. IRT, EDC), • Prepare detailed audit reports, issue non-conformances, and follow through on corrective / preventive actions (CAPAs), • Interface with stakeholders (vendors, partners, CROs, CMOs, investigators) to ensure audit findings are resolved effectively, • Support preparation for regulatory inspections and site audits, • Assist in quality improvement initiatives and continual enhancement of QA processes and practices, • Review and interpret clinical development and safety policies, SOPs, guidelines (e.g. ICH E6, GCP, applicable FDA/EMA regulations), • Provide QA support to cross-functional teams involved in clinical operations, nonclinical, and safety/PV, • Maintain audit schedules, metrics, and quality documentation, • Bachelor’s degree in science, healthcare, life sciences, or related discipline, • Minimum 5+ years in pharmaceutical or biotech industry, • Strong experience in GCP audits (internal/external) and clinical quality assurance, • Familiarity auditing CROs, CMOs, investigator sites, and clinical vendors, • Knowledge of quality systems (QMS), SOPs, compliance documentation, CAPA processes, • Ability to audit clinical systems such as IRT, EDC, and other vendor systems, • Solid understanding of global regulatory guidelines (FDA, EMA, ICH GCP), • Strong report writing, communication, and stakeholder management skills, • Previous experience in neurology, psychiatry, or CNS therapeutic area, • Experience in pharmacovigilance / safety audits, • Office environment, with occasional site or vendor visits, • Ability to travel as needed (≈10%), • Must be comfortable working with and reviewing clinical and audit documentation, • On-site presence required for key audit and inspection events

Job DescriptionAre you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn. This person will participate in the development, writing, and management of highly technical nonclinical documents. This is a full-time, remote position. Roles and Responsibilities: • Strong experience with development and writing of nonclinical documents (eg, Module 2.4 and 2.6 eCTD submission documents, Investigator’s Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents, RTQs), • Lead projects independently with minimal oversight, lead the writing (structure, content and messaging) of nonclinical documents, ensure the nonclinical package aligns with current regulatory guidelines and meets scientific integrity, • Ability to author based on highly technical sources such as GLP and non-GLP nonclinical study reports, in vivo and in vitro nonclinical data, • Ability to develop a mapping plan for the placement of nonclinical studies within structure of Module 2.4 and 2.6 eCTD submission documents, • Interpret and analyze applicable pharmacokinetics, pharmacology, and toxicology data (eg, Prism files, bioanalytical reports, clinical pathology reports, PK/TK evaluation reports), • Collaborate with cross-functional teams such as project management, safety, efficacy, biostats, regulatory operations, and CMC, • Demonstrated ability to lead others to complete complex projects, • Ability to complete documents according to sponsor’s format, processes, and according to regulatory guidelines, • Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment, • Organizational expert within the nonclinical subject area, • Excellent written/oral communication and strong time and project management skills, • Ability to attend regular team meetings, lead client meeting and CRMs, • Ability to work in various client systems (eg, SharePoint, Veeva RIM, PleaseReview, EndNote), templates and toolbars, • Strong understanding of regulatory guidances as it applies to nonclinical submission documents and drug development (eg, ICH, FDA and EMA regulations and guidelines, GLP, GCP, GMP and GDP)Requirements:, • BS + in pharmacology, toxicology, biology or chemistry, or related field, with industry experience within regulatory writing, regulatory affairs, laboratory sciences, quality assurance/control, • Knowledge of GLP, ICH guidelines, and applicable regulatory requirements, • 2+ years of pharmaceutical regulatory nonclinical writing experience, • Strong writing and analytical skills, • Proficiency with MS Office applications., • Hands-on experience with clinical trial and pharmaceutical development preferred uuQhjdtYkG

Job DescriptionCOMPANY OVERVIEW: At F.P. Developments, Inc., we recognize that our employees are our greatest asset. We foster a supportive environment where each team member’s unique strengths and perspectives are valued. Our state-of-the-art, 25,000 sq. ft. climate-controlled facility is a hub for innovation and collaboration, empowering our team to grow both personally and professionally. For 60 years, F.P. Developments has been a cornerstone in the pharmaceutical, biotech, and medical device industries. Established in 1963, we leverage the latest technologies and good old-fashioned ingenuity to solve today’s manufacturing and compliance challenges, consistently meeting our customers' specific requirements with precision and dedication. Join us and be a part of a legacy of quality and innovation. F.P. offers full medical, dental and vision benefits as well as 401k matching, holidays and PTO. SUMMARY: As an Electromechanical field service technician at F.P. Developments, you will train and assist in the fabrication, assembly, electrical wiring, controls programming and servicing of machines and robots used in primary pharmaceutical manufacturing and hospital pharmacy compounding. You will be a self-starter, a quick learner, and open to advancement and travel opportunities. You will also participate in our innovation process, offering suggestions around new capability development. THIS POSITION REQUIRES 10-15% TRAVEL ANNUALLY DUTIES AND RESPONSIBILITIES: • Assembling machines and robots:, • Utilize electrical and mechanical blueprints and schematics to assemble large and small machinery, • Collaborate with engineering and fabrication staff to ensure high quality, durable construction, • Analyze controls programming for PLC and robot automation to troubleshoot and simplify code structure, • Servicing and refurbishing machines and robots (onsite and in the field):, • Troubleshoot and fix machine issues across mechanical, electrical and controls, • Identify and document preventative maintenance procedures for new machines, • Inspect mechanical components for wear and electrical panels for loose and missing components and recommend necessary fixes, • Replace worn or missing parts and ensure machine functionality, • Innovation support, • Research issues and recommend potential solutions, • Stay up to speed with new and emerging technologies applicable to our products, • Education:, • High school diploma or equivalent with electromechanical and controls programming experience OR, • Electrical engineering undergraduate experience, • Skills:, • Mechanical aptitude, • Basic understanding of electrical schematics/wiring, • Basic understanding of PLC programming, • Follow through and follow up, • Strong organizational skills with the ability to manage multiple tasks effectively, • Attention to detail, ensuring all tasks are completed accurately and on time., • Ability to manage time effectively and prioritize tasks in a fast-paced environment, • Customer Service: Exceptional customer service skills with a focus on clear, effective communication and responsiveness to customer inquiries and needs, • Attention to Detail: Meticulous in checking and confirming all aspects of logistics operations, including deliveries, shipments, and inventory, • Openness to Feedback: Highly receptive to feedback, seeking continuous improvement and adjusting based on input from colleagues and customers, • Teamwork: Strong team player, able to collaborate effectively with multiple departments and contribute to a positive work environmentPHYSICAL DEMANDS AND WORK ENVIRONMENT:, • Continually required to stand, walk, sit, • Continually required to utilize hand and finger dexterity, • Occasionally required to climb, balance, bend, stoop, kneel or crawl, • Continually required to talk or hear, • Occasionally required to lift/push/carry items up to 100 pounds, • Frequently required to work near moving mechanical parts and always observe safety precautions, • Ability to travel and work independently The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Powered by JazzHR 79RT1ysAW4

Ethics & Compliance team, responsible for implementing the execution and evolution of Eisais Compliance Monitoring Program. Minimum 7 years of experience in healthcare compliance within the pharmaceutical or biotech industry. Support investigations by conducting data reviews to identify potential co

We help pharmaceutical, biotech, and medical device organizations overcome complexity, accelerate timelines, and stay audit-ready.We are currently seeking to identify.While there may not be an immediate vacancy, we encourage you to apply if you meet the qualifications.Qualified applicants will be co

Experience in preparing and prosecuting patent applications in the areas of molecular biology, immunology, immuno-oncology, genetics, and agricultural biotechnology would be particularly useful.

Job Description Tiger Analytics is an advanced analytics consulting firm. We are the trusted analytics partner for several Fortune 100 companies, enabling them to generate business value from data. Our consultants bring deep expertise in Data Science, Machine Learning, and AI. Our business value and leadership have been recognized by various market research firms, including Forrester and Gartner. We are seeking a dynamic and technically accomplished Director of R&D Advanced Data & Digital Platforms Product Management to lead the product management function for digital, data, and analytics platforms supporting pharmaceutical R&D. This role is critical to building and scaling the foundational platform capabilities that enable advanced analytics, machine learning, and data science across the R&D organization—including preclinical, translational, and clinical research workflows. Reporting to the Head of R&D Digital Platforms, this role will define and execute the platform strategy that supports cross-R&D solution delivery, ensuring alignment with scientific goals, regulatory requirements, and enterprise digital strategies. You will lead a team of product managers and analysts while collaborating closely with R&D, data science, and digital technology partners to deliver secure, scalable, and high-performance capabilities. The ideal candidate will bring strong expertise in R&D technology enablement, platform product management, and agile software delivery, with the ability to adapt strategies to meet the unique needs of scientific workflows across discovery, preclinical, translational, and clinical domains, as well as stakeholder and regulatory environments. RESPONSIBILITIES: • Leadership & Strategy, • Define and drive the vision, strategy, and roadmap for advanced digital and data platforms in R&D., • Lead and grow a high-performing team of product managers and analysts., • Foster a culture of innovation, agility, and customer-centricity., • Partner with scientific, digital, and enterprise leaders to align product strategy with R&D and business priorities, including preclinical research requirements., • Technical Product Management, • Own the end-to-end lifecycle of platform capabilities—from ideation and design to delivery and continuous improvement., • Ensure solutions are designed with a deep understanding of user needs, preclinical and clinical scientific workflows, developer requirements, and regulatory constraints., • Champion agile product development practices and iterative delivery models., • Establish and track KPIs to measure platform success, adoption, and impact., • Collaboration & Stakeholder Engagement, • Act as primary liaison between solution delivery and platform teams to identify reusable capability opportunities., • Collaborate with engineering, data science, and informatics teams to ensure timely and high-quality delivery across discovery and preclinical research use cases., • Engage with external partners, vendors, and academic collaborators to accelerate innovation., • Promote adoption of platform management best practices and share lessons learned across the organization., • Governance & Compliance, • Ensure adherence to internal governance, data privacy, and regulatory standards., • Promote responsible data and AI practices including transparency, fairness, and explainability., • Support audit readiness and documentation for platform development processes., • Team Leadership, • Build and mentor a team of product managers and analysts, fostering technical excellence and accountability., • Guide career development through coaching, feedback, and structured growth opportunities., • Promote cross-functional collaboration across science, data, and IT., • Inspire the team to navigate evolving priorities, emerging technologies, and scientific complexity., • Strategic Impact, • Contribute to the overall R&D digital platform strategy and roadmap., • Evaluate and adopt emerging technologies to future-proof R&D capabilities., • 10+ years of experience in technical project delivery/product management, with at least 5 years focused on advanced data, analytics, or digital platforms., • Proven track record of building and operating large-scale data/ML platforms in a scientific or regulated environment., • Strong background in pharma, biotech, or healthcare; direct experience in preclinical, discovery, or translational R&D highly desirable., • Exposure to domains such as preclinical workflows, discovery research, real-world data, or clinical informatics., • Fluency with pharma data sources such as Veeva and IQVIA (Plantrak, LAAD, PE, etc.), and real-world data (RWD) sources like TriNetX, Flatiron, Optum, and Komodo, combined with strong familiarity with regulatory requirements including GxP and HIPAA for R&D data., • Demonstrated success influencing stakeholders in a matrixed environment., • Expertise with agile methodologies, product lifecycle management, and cross-functional team leadership., • Exceptional leadership, communication, and stakeholder management skills. Significant career development opportunities exist as the company grows. The position offers a unique opportunity to be part of a small, fast-growing, challenging and entrepreneurial environment, with a high degree of individual responsibility. Tiger Analytics provides equal employment opportunities to applicants and employees without regard to race, color, religion, age, sex, sexual orientation, gender identity/expression, pregnancy, national origin, ancestry, marital status, protected veteran status, disability status, or any other basis as protected by federal, state, or local law.

Job Description About Us Second Melody is a strategic branding studio with a broad client portfolio, including health and biotech corporate communications. Our mission is to help our clients solve problems by building stronger and more inclusive brands that accurately represent their visions, passions and business goals. We create powerful brand communications that drive engagement, elevate perception, and make the world more beautiful. Role Overview We’re looking for a Designer (Motion) to join our team. You’ll create bold, thoughtful, and refined design solutions—from visual identity systems to motion graphics—across digital, social, and print. This role is perfect for someone who thrives on strategy-driven creativity, has a sharp eye for detail, and wants to grow as part of a collaborative, high-performing team. Your work will directly shape brand perception, audience engagement, and marketing effectiveness for clients who choose us for both what we do and how we do it. Job Responsibilities What You’ll Do • Independently research and develop unique concepts that can expand into full campaigns and Brand ID’s, • Design and expand visual identity systems and campaign materials across print, digital, and social, • Create and animate assets for web, social, and brand storytelling, • Collaborate with the Head of Creative and team to translate strategy into smart, impactful design, • Present and refine design concepts, iterating with feedback to meet client goals Leadership & Collaboration • Contribute to a creative, knowledge-sharing culture while mentoring junior designers, • Collaborate with cross-functional team members to deliver on creative briefs, client expectations, and in accordance with brand guidelines What You Bring • 4+ years of agency experience (health, pharma or sustainability a plus), • Proven design and motion experience with a strong portfolio, • Mastery of After Effects, Illustrator, Photoshop, InDesign, and Figma, • Strong eye for typography, layout, and visual rhythm, • Ability to juggle multiple projects, meet deadlines, and stay solutions-focused, • Open, collaborative mindset—comfortable with feedback and iteration, • Highly organized, detail-driven, and on top of trends in design and tech What We Value • A balance of task focus and people skills—able to collaborate with clients and colleagues alike, • Organized, resourceful, and proactive in managing multiple projects, • Exercises good judgment and knows when to ask questions or seek guidance, • Trustworthy and professional with sensitive information, • Driven, energetic, and committed to delivering high-quality work on time Time Off • Vacation - 12 days, • Personal - 12 days, • Sick - 5 days, • Medical insurance, Second Melody covers 75% of the employee's premium (available after 2 months of full-time employment), dependents can enroll at full premium, • Opportunity for promotion and internal career advancement available as necessary skills are developed and the company grows Why Join Us At Second Melody, you’ll help build brands that matter while growing your craft in a supportive, ambitious environment. We value collaboration, curiosity, and creativity—and we’re committed to work that inspires and endures. Salary Range: $50,000-$55,000

Job Description About Us: Second Melody is a branding studio with a diverse client portfolio, including a strong presence in health and biotech. Our focus is strategic brand alignment across corporate messaging, internal culture, audience outreach, advocacy and education. Our mission is to help our clients solve problems by building stronger and more inclusive brands that accurately represent their visions, passions, and business goals. Role Overview: At Second Melody, we believe in building meaningful, lasting relationships with our clients and within our team. As a Senior Account Manager, you’ll support those connections by serving as a primary contact between clients and internal teams, ensuring clear communication, alignment, and client satisfaction. Working closely with the Director of Accounts and cross-functional team members, you’ll manage day-to-day communications, ensuring the strategic direction of the brand is aligned to projects and client needs are met. You will build, maintain, and grow relationships with clients, leading to organic growth. This is a client-facing role suited for someone organized, curious, and eager to lead in a purpose-driven creative environment. Job Responsibilities Business Management & Development • Manage the development of scopes of work and annual budgets for assigned account(s) in partnership with internal team, • Oversee estimates, billing, job closeouts, and financial tracking to support account profitability; ensure team compliance with Teamwork for accurate billing, • Identify organic growth opportunities by understanding client goals and making suggestions to supervisor and ultimately client, • Participate in internal brainstorms and planning sessions, contributing ideas and capturing action items aligned to client strategic objectives, • Build knowledge of brands, market, and business objectives; monitor market and competitive trends, • Participate in new business pitches as opportunities arise Client Relationship • Serve as day-to-day client contact for assigned clients, managing daily communication, setting expectations, and building trusted relationships, • Lead client meetings, tactical project discussions with strategic references, and status calls, ensuring clear documentation of decisions and action items; attend workshops and conferences, • Develop Project Briefs that align with client objectives, timelines, and budgets; provide clear direction and strategy to internal team members, • Review and approve creative deliverables before client presentation, ensuring strategic alignment, accuracy, and consistency with the Brief, • Lead tactical project execution, addressing client feedback and challenges with timely solutions; capture feedback, asking strategic questions to guide revisions and maintain project focus, • Operate within internal workflows and client processes throughout project lifecycle, • Set and manage client expectations regarding deliverables, timelines, and budgets Leadership & Collaboration • Foster and inspire a deeply collaborative atmosphere and culture, • Present work to clients for approval with cross-functional team members; solicit feedback on tactical execution, • Collaborate with cross-functional team members to deliver on Project Briefs, client expectations, and in accordance with brand guidelines, • Deliver work on time and in accordance with budgeted hours, • Work within agency systems and processes People Management What You Bring • 3+ years of pharmaceutical/biotech industry (in-house) or pharmaceutical/biotech agency experience managing branding-related projects across various mediums including but not limited to digital, print, environmental and events, • Ability to juggle multiple projects, meet deadlines, and stay solutions-focused, • Excellent written and verbal communication skills, • Experience presenting to clients, • Open, collaborative mindset—comfortable with feedback and iteration, • Detail oriented, organized, and proactive nature that anticipates client and internal team needs, challenges, solutions, • Proficient with Google Docs (including slide development) and agency workflow/project management systems, • Willingness to travel for client meetings or workshops as needed What We Value • A balance of task focus and people skills—able to collaborate with clients and colleagues alike, • Organized, resourceful, and proactive in managing multiple projects, • Exercises good judgment and knows when to ask questions or seek guidance, • Trustworthy and professional with sensitive information, • Driven, energetic, and committed to delivering high-quality work on time, • A genuine alignment with Second Melody’s mission and growth Hybrid Structure: While Second Melody’s offices are located in New Jersey, candidates are not required to reside in the state. However, they should be willing to travel to New Jersey for company events as needed. Benefits Time Off • Vacation - 12 days, • Personal - 12 days, • Sick - 5 days, • Medical insurance, Second Melody covers 75% of the employee's premium (available after 2 months of full-time employment), dependents can enroll at full premium, • Opportunity for promotion and internal career advancement available as necessary skills are developed and the company grows Salary Range: $85,000-$90,000

Job DescriptionProvides administrative and secretarial support for the vice president and department. RESPONSIBILITIES • Monitors and oversees facility operations for a large biotech site., • Troubleshoots and performs repairs on system issues involving electronic, electrical, pneumatic, hydraulic, and mechanical devices, Johnson Controls Metasys BMS, utility, and water systems., • Supervisor in charge of facility housekeeping staff for second shift., • Generates work orders in SAP, participates in site emergency response and Hazmat activities. Novartis Pharmaceuticals 01 Sep 2005 - 01 May 2014 ENGINEERING TECHNICIAN 1216 5th Avenue New York NY , 10029 OK to contact this employer? - No RESPONSIBILITIES • Repaired, maintained, and calibrated pharmaceutical manufacturing, production and packaging equipment.

Job DescriptionEMPLOYMENT OPPORTUNITY WITH MARCHESINI GROUP USA Seeking an Experienced SALES Manager/Director to generate and handle sales for our Beauty Division line of packaging machinery. Who we are… Marchesini Group USA is a leading supplier of primary and secondary packaging solutions to the pharmaceutical, biotech, and cosmetic industries. Established in 1992, our 23,000-square-foot North American headquarters supports the USA, Canada, and parts of the Caribbean and is backed by 2,500 Marchesini staff members worldwide. Our modern facility is equipped and staffed to meet the ever-increasing demands of today’s sophisticated and quality-conscious packaging clients. In today’s high-tech global marketplace, you need the right people and a commitment to providing the highest level of innovation, craftsmanship, reliability, and service. Our years of collective experience are at the service of our clients every day. Every member of Marchesini Group USA is here to satisfy our clients’ packaging requirements in the most effective way possible. Our sales team comprehensively analyzes and defines the customer’s packaging requirements to translate technical challenges into effective unique packaging solutions. By combining the most-advanced technology with our knowledge and understanding of the pharmaceutical, cosmetic and consumer products industries, we have made solving packaging challenges our specialty. All precision packaging machinery available through Marchesini Group USA has been manufactured to meet the highest level of quality certification using established production benchmarks and testing procedures. No single element of our business is as important to our reputation and our success as quality…and it has never been compromised. About the position… RESPONSIBILITIES AND ESSENTIAL FUNCTIONS: • Develops, generates and manages sales activity for beauty/cosmetic sector customers., • Manage and generate sales activity for large key accounts as well as small to mid-size customers., • Executes the complete sales cycle from initial contact onwards., • Creates and maintains strong working customer relations., • Maintains and manages customer data base and reports in CRM., • Sales forecast planning., • Drives growing sales in expanding market.The person... Pivotal Experience & Expertise Functional Experience: Brings strong commercial experience. Demonstrates an independent, results-driven work ethic. A self-starter and team player who is motivated to succeed. Superior people/customer relationship skills as well as strong interpersonal skills. Industry Experience & Tenure: Minimum of 5 years’ broad experience and knowledge of cosmetic processes and packaging equipment. Brings strong network connections and relationships. Business Acumen: Understands business implications of decisions. Displays orientation to profitability. Demonstrates knowledge of market and competition. Aligns work with strategic goals. Competencies: • Adaptability: Adapts to changes in the work environment. Manages competing demands and changes approach or method to best fit the situation., • Collaboration and Teamwork: Balances team and individual responsibilities. Contributes to building a positive team spirit., • Customer Service: Focuses on serving customers as the organization’s top priority. Understands needs, creates distinctive value, and builds meaningful relationships. Aligns organization and resources to deliver on customer commitments. Driven to create value for customers., • Expert Communication: Excellent verbal and written communication skills. Responds promptly to customer needs to meet commitments., • Innovation: Displays original thinking and creativity and meets challenges with resourcefulness., • Learning: Curious, open-minded and an avid listener who welcomes broad input, criticism and feedback., • Motivation: Sets and achieves challenging goals. Demonstrates persistence and overcomes obstacles and measures self against standard of excellence., • Planning/Organizing: Prioritizes and plans work activities while efficiently managing time., • Problem Solving: Identifies and resolves problems in a timely manner. Gathers and analyses information skillfully and develops alternative solutions. Microsoft O365 including Excel, Word, OneDrive, Outlook, PowerPoint, SharePoint, Teams. Benefits: The well-being of our employees and their families is our top priority. Therefore, Marchesini Group USA offers a generous and attractive benefits packaging including: Paid Time Off • Paid Holidays • Pension Plan • 401(k) Plan • Medical Insurance • Dental Insurance • Vision Insurance • Short- and Long-Term Disability Insurance • AD&D Insurance • Life Insurance • Employee Assistance Program • Optional Identity Theft Protection Coverage • Car Allowance (for applicable sales positions) Work Status Eligibility and Requirements: Applicants must have a pre-existing legal US work status. Will not sponsor visas. Travel 60%+ Additional Language Knowledge: Not required but always a plus! ITALIAN/SPANISH LANGUAGE Salary: $90,000 to $115,000 annually depending on experience level + commission Job Location: Position is a Remote/Telecommuting Position. Powered by JazzHR kANZiAEOd0

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