- Genmab (Plainsboro, NJ)
- …time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy, Global Regulatory Affairs, the key responsibilities include ... and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role,...working group meetings, as required for the assigned projects Lead the strategic development of briefing materials and prepare… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks related to final printed pharmaceutical labeling for launch and ... device labels. The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global HQ, Labeling… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …collaboration with consistent communication across stakeholders ( Global Research, Global Development, Market Access, Marketing, Regulatory Affairs, Safety, ... key external partners Cross-functional collaboration - Global Research, Global Development, Strategy Access Marketing, Medical Affairs Regulatory Safety,… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.Overview The Global Clinical Trial Manager, Team Manager (GCTM-TM) is responsible for line management ... and strategic support across trials as needed and may assume Global Clinical Trial Manager (GCTM) responsibilities to address fluctuating demands throughout… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Director Global Market Access & Pricing Hematology will be responsible for developing and ... executing differentiated global market access and pricing strategies demonstrating the value...regional healthcare systems, payer preferences, and market dynamics to lead the market access and pricing launch strategies.This position… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Early Development, Development, innovation hubs across NN, other affiliates, and global . We're looking for individuals who are enterprise thinkers, inclusive ... on shaping our future. The Position The Hemophilia TA Lead is instrumental in shaping and executing NNI's strategic...competitive market landscape. This role also contributes to the global TA strategy by working closely with global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach resolution.Participate in global ... assigned to alliance assets for operational matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA… more
- Genmab (Plainsboro, NJ)
- …across various markets within cancer treatment.We are now looking for a Clinical Project Lead (CPL) to join the team, who will be responsible for oversight of a ... program of global studies, covering all clinical development deliverables.The role is...the Clinical and Compound Development Plans developed by the CDT. Lead and coordinate cross functional Development Operations input and… more
- Genmab (Plainsboro, NJ)
- …needs of the US healthcare market through collaboration with US Commercialization, Global Medical Affairs, Clinical Development, Regulatory , and other cross ... Hematology Strategy will report to the Director, US Medical Affairs Hematology Strategy Lead . S/he will assist the strategy lead to providing medical affairs… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent, ... Relationships Reports to the Senior Director /Director Program Management Lead . Key internal relationships include brand marketing, market access, Enterprise… more
- Genmab (Plainsboro, NJ)
- …trials, medical review and communication of data, and medical input into regulatory documents and presentations.Responsibilities: Lead the development of the ... diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and...in the development of the clinical development plan (CDP). Lead creation and review of clinical components of key… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a consistent brand/therapeutic area vision and message. Relationship Reports to Brand Lead or HCP/KOL Strategy Lead . Collaborates with cross-functional teams, ... affairs, market access and policy/advocacy (MAPA), Centres of Excellence (COEs), regulatory affairs, other relevant NNI departments, and external stakeholders to… 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
- Genmab (Plainsboro, NJ)
- …Director, Privacy Technologist & Third-Party Privacy Risk reporting into the Head of Global Data Privacy Program, will serve a pivotal role at Genmab by contributing ... to the development and ongoing maintenance of key components of Genmab's Global Data Privacy Program. In this role, you will be responsible for two critical Program… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent, ... commercial insights and analytics, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs, Government Affairs &… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent, ... Supply Chain, Procurement, Public Affairs, Public Policy, Managed Markets, Regulatory , Legal, IT, Trade, Product Safety and Compliance. External relationships… more
- Genmab (Plainsboro, NJ)
- …CPQS in the Translational and Quantitative Sciences Leadership Team and lead strategic development of pre-clinical and clinical pharmacology strategies for Genmab's ... a culture of continuous learning and improvement.This is an exciting opportunity to lead a passionate, high profile, high-impact Pharmacology team, and work in a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partners closely with Market Research, Competitive Intelligence, Marketing, MA, R&D, Finance, Regulatory and Market Access internally across global and regional ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... and prioritize improvement opportunities with the greatest impact.Process Optimization Lead initiatives to standardize, simplify, and optimize core processes across… more
