- 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)
- …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
- 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
- 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)
- 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
- 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
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Partnerships and Engagement, Customer Experience and Marketing Enablement, Employee Experience, Regulatory , PRB, PSP, FRM, Conventions, Global Marketing, Launch ... Early Development, Development, innovation hubs across NN, other affiliates, and global . We're looking for individuals who are enterprise thinkers, inclusive… 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Experience (UDX) strategies. In this position, the Non-Regulated Implementation Services Lead will collaborate closely with cross-functional Global DX teams, ... 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)
- …pharmaceutical/oncology project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA ... medicines to help people. 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)
- …that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs), who are ... collaboration with the Global RD/PV QA team.RESPONSIBLITIESProgram oversight: Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs) by… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other departments to ... from clinical trials or post-marketing for completeness, accuracy, expectedness and relatedness. Lead internal and external (especially regulatory , but also… 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
- 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 ... Development will be responsible for providing legal counsel to Daiichi Sankyo's Global Business Development department and handle all legal aspects of licensing,… more
