- Merck & Co. (North Wales, PA)
- …accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to ... Brochures before release from our company to external agencies and investigators.Represents Global Regulatory Affairs (GR) within internal committees to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Manager , Regulatory Affairs - Regulatory Project Management ... and coordination supports for global and US regulatory activities. The Manager RPM is responsible... Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …This individual works cross-functionally with internal and external departments on Regulatory Affairs labeling related issues. Relationships Reports to labeling ... rapport and working relationships with company stakeholders. Effective collaboration with Regulatory Affairs , CMR, Supply Chain, and HQ colleagues regarding… 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)
- …internal and external stakeholders. Internally, they may partner with the Local and Global Clinical Operations, regulatory affairs , medical affairs , ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...NACD SME on clinical trial diversity for local and global forums, initiatives, and communications Identify and develop partnerships… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. Position is ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Global HQ. Key internal relationships include Field Medical Affairs , Medical Strategy & Operations, Medical Information, Publications, Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Division of the Company (including, for example, Market Access, Sales, Marketing, Medical Affairs ) as well as DSI employees performing Global roles in the ... limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside...United States (such as Global Marketing, Global Medical Affairs ). For these areas, acts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory… more
- Genmab (Plainsboro, NJ)
- …this role will include stakeholders in the business domains Field Operations, Medical & Regulatory Affairs and US and Japan Market and Commercial Teams (and ... teams. As security leader you are part of a global information security team with main focus on stakeholders...and Genmab Security Operations TeamBusiness leaders (eg, VP Medical Affairs , VP Regulatory Affairs , GM… more
- Merck & Co. (Rahway, NJ)
- …and Translational Medicine, Global Medical and Scientific Affairs , and Global Regulatory Affairs and Clinical Safety to identify key issues ... expected to collaborate with our Research & Development Division colleagues from Global Clinical Development, the Center for Observational and Real-World Evidence, … more
