- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Device Development and Commercialization process.Experience with developing and documenting regulatory strategies in coordination with clinical plans and ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the ... International). Eisai Salary Transparency Language:The base salary range for the Associate Director , Global Medical Affairs Training and Education is from… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... any time throughout the annual performance cycle. Relationships Reports to Executive Director or Vice President Medical Affairs . Has direct supervisory… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning and execution ... of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include… more
- Merck & Co. (North Wales, PA)
- …and reimbursement. The incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial, and ... and barriers to reimbursement and market access, and provides input into clinical , regulatory , payer/access, marketing and evidence generation strategies and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
- Genmab (NJ)
- …various regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director , ... like a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for… more
- Merck & Co. (Rahway, NJ)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and ... Interdisciplinary Problem Solving, Mentorship, Neuroanatomy, Pharmaceutical Development, Pharmacovigilance, Psychiatry, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Merck & Co. (Rahway, NJ)
- …HTA submissions. The incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and ... and barriers to reimbursement and market access, and provide input into clinical , regulatory , payer/access, marketing and evidence generation strategy and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... industry required Proven knowledge of the pharmaceutical industry, including medical, regulatory , clinical processes and market dynamics, especially within… more
- Merck & Co. (Rahway, NJ)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; ... clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be… more
- Eisai, Inc (Nutley, NJ)
- …on opportunities for evolution and differentiation.Collaborate with our Global Marketing, Clinical Development, and Government Affairs on the go-to-market ... If this is your profile, we want to hear from you. The Director , HCP Marketing, Alzheimer's Disease will lead several core marketing, strategy, and lifecycle… more
- Merck & Co. (North Wales, PA)
- …role will focus on supporting HPV. Under the guidance of an Executive Director , within the Value and Implementation, Outcomes Research the incumbent has the ... of patient reported outcomes, epidemiological studies and economic modeling.The Director also works closely with Product Development Teams, Franchise Teams,… more
- Ascendis Pharma (Palo Alto, CA)
- …States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director , Regulatory Affairs will serve as the therapeutic area ... important new medicines for devastating diseases. This position will report to the VP, Regulatory Affairs and ideally be based in the Ascendis Pharma corporate… more
- Philips (Plymouth, MN)
- The Director , Regulatory Affairs will lead the Philips RespirTech InCourage Vest Therapy Regulatory Affairs and Quality teams in the development and ... quality team/quality management system (QMS) responsibilities. **Your role:** + Lead Regulatory Affairs strategy end-to-end execution (product inception through… more
- Sanofi Group (Morristown, NJ)
- …The Associate Director collaborates closely with cross-functional teams, including Global Regulatory Affairs , Clinical Development, Safety, and Medical ... **Job Title:** Associate Director , Global Regulatory Affairs ...Director contributes to early development activities by providing regulatory input into clinical development plans, including… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the Job** Are ... be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs -...Provide regulatory labeling leadership to cross-functional teams ( Regulatory Strategy, Clinical Development, Medical Affairs… more
- Abbott (Lake Forest, IL)
- …Opportunity** Our location in **Lake Forest, IL** currently has an opportunity for the ** Director of Regulatory Affairs .** The function of a Director ... metrics/information. The individual may plan, direct, coordinate, and control the regulatory affairs activities related to products worldwide. **WHAT YOU'LL… more
- Ascendis Pharma (Palo Alto, CA)
- …offer a dynamic workplace for employees to grow and develop their skills. The Director , Regulatory Affairs will be responsible for developing and ... and regulatory colleagues. + Contributes to the development of global clinical regulatory plans and strategies, identifies, and proposes risk mitigation… more
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