- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Vice President, Regulatory Affairs , General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and ... an effective implementation and oversight model to maintain best-in-industry regulatory compliance.The Vice President Regulatory Affairs ,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … procedures. Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization ... coordination with clinical plans and marketing objectives. Experience with communicating the regulatory strategy , issues, and risks in written and verbal format… more
- Merck & Co. (Rahway, NJ)
- …broad experience in Animal health commercial operations, R&D, and Regulatory Affairs -Expertise in project management, business adoption/change management, ... Job DescriptionThe US CA Veterinary Insights and Medical Affairs Director sets the strategic vision for the...Team to provide guidance from a medical perspective on strategy and tactics that ensure compliance and alignment with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 30% overnight travel required; Qualifications MD ... Nordisk Inc. and Global HQ. Key internal relationships include Field Medical Affairs , Medical Strategy & Operations, Medical Information, Publications, Clinical… more
- Eisai, Inc (Nutley, NJ)
- …Medical Director, US Medical Affairs provides medical leadership for medical affairs strategy , planning and supportive tactics for assigned therapeutic ... key business processes. Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs and Commercial… 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)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Eisai, Inc (Nutley, NJ)
- …you. Job Summary The Medical Director will provide medical leadership for medical affairs strategy , planning and supportive tactics for assigned therapeutic ... key business processes. Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs and Commercial… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …BD&L. Collaborates with cross-functional teams, including portfolio, marketing, medical, R&D, regulatory affairs , analytics, and other relevant NNI departments ... states. Work collaboratively with cross-functional teams including research and development, regulatory affairs , and commercial teams, to align product… more
- Merck & Co. (North Wales, PA)
- …position will require outstanding leadership in multiple areas including scientific strategy building, scientific leader engagement, advisory board planning , ... for the position of Associate Director, US Oncology - Hematology Scientific Strategy . This talented individual will lead the development of deep therapeutic insights… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- … affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , and other relevant NNI departments to ensure alignment ... be a pivotal driver in shaping an insights-driven consumer marketing strategy , advising omnichannel execution planning , and measuring marketing effectiveness.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Asset Owner. Collaborates with cross-functional teams, including marketing, medical, R&D, regulatory affairs , finance, NNI Global, Market Access (MAPA) and ... with regulatory guidelines and industry standards, working closely with regulatory affairs teams to address any compliance-related issues Commercialization… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery ... multiple programs. The CS group lead will also contribute to the program study strategy , planning , execution, and reporting outputs in collaboration with the CS… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Global Oncology Medical Affairs to integrate diversity considerations into study planning and execution- Partner with Disease Area Strategy Team (DAST) ... partners, including but not limited to: Global Clinical Operations, Global Regulatory Affairs , Biostatistics and Data Management, Epidemiology, Patient Advocacy,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Pharmacology; Attends regulatory agency meetings and leads clinical strategy discussions- Study planning and execution: Develops prospective contingency ... at meetings with health authorities; Leads the creation of developmental and regulatory strategy ; Accountable for performance of CROs; Routine interactions with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …programs.- Partner and collaborate with Clinical Operations, Biostatistics and Data Management, Regulatory Affairs and other RD functions to ensure effective ... life cycle. The CS lead will also contribute to the program study strategy , planning , execution and reporting outputs. CS lead responsibilities include… more
- Merck & Co. (North Wales, PA)
- …the brandPartner with multiple stakeholders including Sales and IAM leadership in planning and execution of strategy , customer engagement and promotionPartner ... Team (CAT) while taking ownership of Brand and HCP Strategy and Execution. This position will report to the...meeting strategic priorities and quarterly objectives; lead agile quarterly planning stages to enable teams to quickly and effectively… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , and other relevant NNI departments to ensure alignment ... About the Department Our Commercial Strategy and Marketing group creates and delivers human-centered experiences, where innovation meets customer-centricity, driving… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cross-functional project teams, including Clinical Development, Clinical Operations, Biometrics, and Regulatory Affairs personnel to manage preparation of the ... written deliverables that support the clinical development and regulatory requirements of a clinical program. The Director will provide high level strategic input… more
