- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionThe Global Director Medical Affairs (GDMA) Oncology Assets & Pipeline coordinates the development and implementation of the Global Medical ... edge of therapeutic and patient care advances. The GDMA coordinates medical affairs activities to resolve regulatory , reputational, ethical, and other asset… more
- Merck & Co. (North Wales, PA)
- …promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launchUnderstanding of the product ... Job DescriptionReports to the Director /Senior Director in the Office of...strategy discussions and extended team meetings and providing regulatory guidance and perspective on marketing strategies and promotion… more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.-Specifically, the Director may be… more
- Merck & Co. (North Wales, PA)
- Job DescriptionKey Responsibilities: Lead overall Scientific Strategy development and execution for Pneumococcal Vaccines FranchiseLead annual scientific strategy ... with cross-functional teams to ensure alignment with the overall product strategy and messagingBuild and maintain strong relationships with Scientific Leaders; 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... Safety Scientists. Contributes and provides oversight in the development of safety strategy and safety deliverables for assigned programs within the US East Coast… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …TA priorities and business needs. Relationships This position may report into the Field Director , Medical Affairs (or in smaller TA's directly into the TA head). ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...scientific resources, communications, and training initiatives for the medical affairs team Serve on Clinical Trial Strategy … 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 ... to prepare for launch, development and/or life cycle activities Health Systems strategy : Collaborates with medical affairs and market access teams to… more
- Tris Pharma (Monmouth Junction, NJ)
- …compliant communication between marketing and other cross-functional teams (ie, Medical Affairs , Sales, Regulatory Affairs , Operations, etc.)Collaborates ... distribution, promotion etc.Deep knowledge of the pharmaceutical Legal, Medical, Regulatory review processDemonstrated experience in driving marketing strategy … 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …areas during their rotations. Additional key internal relationships may include Medical Affairs , Regulatory Affairs , Marketing, Learning & Development, ... Essential Functions Fellow will collaborate with cross-functional areas including Medical Affairs , Regulatory Affairs , Marketing, etc. This structured… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …industry experience (including roles in research and development (R&D), clinical trials, regulatory affairs , or medical affairs Leadership Experience: Proven ... and future markets and business needs and leverage medical, scientific and regulatory opportunities. In agreement with the individual Project Vice President (PVP),… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …, PCOR, Finance, Brands, Medical Affairs , HEOR, Future Business Strategy , Commercial, Account Management, Analytics, Legal, Regulatory , Investor Relations, ... About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …market access, commercial effectiveness, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... & independently in order to accomplish objectives. Relationships Reports to the Director , Patient Support. Key internal relationships include brand marketing,… more
- J&J Family of Companies (Skillman, NJ)
- …RA Dietary Supplements - 2407024953W **Description** Kenvue is currently recruiting for: Director , Regulatory Affairs , Dietary Supplements This position ... reports to the Senior Director , Regulatory Affairs and is...Regulatory Affairs is responsible for developing regulatory strategy and providing guidance to product… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #386 Tuesday, August 20, 2024 Looking for a chance to make a ... expanding mid-size oncology company in the role of Associate Director , Regulatory Affairs Operations where...years of pharmaceutical industry experience in developing and implementing regulatory submissions strategy for early and late… more
- Ascendis Pharma (Princeton, NJ)
- …We offer a dynamic workplace for employees to grow and develop their skills. The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for ... labeling, and for coordinating internal labelling activities and processes for regulatory submissions and product maintenance. The Associate Director prioritizes… more
- Bristol Myers Squibb (Princeton, NJ)
- …careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of ... regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration with...with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience… more
- Merck (North Wales, PA)
- …the promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launch + Understanding of the ... **Job Description** Reports to the Director /Senior Director in the Office of...strategy discussions and extended team meetings and providing regulatory guidance and perspective on marketing strategies and promotion… more
- Bristol Myers Squibb (Princeton, NJ)
- …7-10+ years Pharmaceutical industry experience, including multi-disciplined experience, 6+ years CMC regulatory strategy . + Knowledge of CMC regulatory ... database to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for content development,… more
