- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible ... Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report...programs, target product profile, and competitive labeling precedent.Act as Global Labeling Lead , supporting development, approval and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Safety Surveillance and other cross functional teams. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of ... internal and external stakeholders. Relationships This position will report to Senior Global Safety Lead /Director/Senior Director - Safety Surveillance, US East… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Respiratory will focus on driving strategy, development, and life-cycle ... & Respiratory Therapeutic Area (CV&R). The incumbent will be expected to lead multiple programs including those new to the organization therefore requiring someone… more
- Merck & Co. (Rahway, NJ)
- … regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device Development & ... ensure full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key Ofunctions. Lead the Device… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The HCP - Strategy Lead (MASH) lead will be a pivotal driver in shaping an insights-driven HCP ... area vision and message. Relationships Reports to the Integrated TA Strategy Lead . Responsible for providing interface with key internal and external stakeholders.… 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 ... our future. The Position The Rare Bleeding Therapeutic Area Lead is instrumental in shaping and executing NNI's strategic...for the TA. This role also contributes to the global TA strategy by working closely with global… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as Diabetes and Bio Pharm Field Sales, Managed Care, Trade and Government, Medical, Regulatory , Legal personnel and may advise Global Teams with regard to ... and HCP program operations and technology systems. This position will also lead the development of operational business plans to meet evolving regulations and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research ... forward momentum, and an inspiring mission to achieve new milestones in global healthcare. The Biologics and Biopharmaceutics team is responsible for the research… 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 Ecosystem & Enterprise Influence Lead is responsible for driving strategic initiatives to address the complex challenges… more
- Merck & Co. (Rahway, NJ)
- …Distinguished Scientist (Executive Director) and Product Development Team (PDT) lead , Oncology Global Clinical Development, has primary responsibility ... to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications...the field of breast cancer. The Executive Director, PDT lead will manage the entire cycle of clinical development,… 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
- Merck & Co. (Rahway, NJ)
- …and materials characterization tools and techniquesExtensive knowledge of technical and global regulatory requirements for medical devices and combination ... Job DescriptionThe Senior Director of Device Product Stewardship will lead a department of up to 15-20 personnel overseeing technical support and product stewardship… more
- Merck & Co. (Rahway, NJ)
- …and other pharmacometric analyses-Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …East Coast Hub (ECH) in collaboration with Employee Experience (EE)/P&O NAO and Global onboarding initiatives Lead a team of Role-Specific Training Support ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Therapeutic Areas). They are responsible to ensure alignment to global and HR training and onboarding plans. They will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …business management team, as well as the broader North America Clinical, Medical and Regulatory (CMR) function and global stakeholders in Global Development ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...trial strategy and execution to targets. Co-leads communication to global and local stakeholders to ensure consistency. Proactively identifies… more
- Genmab (Plainsboro, NJ)
- …needs of the US healthcare market through collaboration with US Commercialization, Global Medical Affairs, Clinical Development, Regulatory , and other cross ... report to the Senior Director, US Medical Affairs Solid Tumors Strategy Lead . S/he will provide medical affairs leadership for assigned asset(s)/indications and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Channel Strategy Owner, Customer Portal reports directly into the Channel Strategy Lead , Owned. This role will regularly interface with their direct reports (Channel ... Area leads, Sales, Patient Support Program, CIA&A, Medical, Legal, and Regulatory and IT. Essential Functions Portal Strategy Development: Leading the development… more
- Genmab (Plainsboro, NJ)
- …expert supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as trial responsible ... contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct as lead and main point of contact related to Statistics for… more
- Genmab (Plainsboro, NJ)
- …architects and Genmab Security Operations TeamBusiness leaders (eg, VP Medical Affairs, VP Regulatory Affairs, GM Genmab US, IT Lead in Japan)Peers within IT&D, ... teams. As security leader you are part of a global information security team with main focus on stakeholders...stakeholders in the business domains Field Operations, Medical & Regulatory Affairs and US and Japan Market and Commercial… more
