- Aequor (Newbury Park, CA)
- … Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization. To coordinate and execution of US regulatory ... Lead to manage GRT interactions The responsibilities of the Regulatory Affairs Senior Associate position are: Assist...with Regional Regulatory Lead Create and maintain product regulatory history documents through systems and… more
- Genmab (Plainsboro, NJ)
- …to fulfilling our purpose.The Role As part of our expanding US Medical Affairs (USMA) team, Genmab is seeking a Senior Director, USMA Solid Tumor Portfolio. ... role will report to the VP/Head of US Medical Affairs and will be responsible for building and leading...key member of the USMA leadership team, contributing to product launches & development efforts, responsible for shaping team… 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...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Expert understanding of the pharmaceutical industry including marketing, medical, access, public affairs , compliance, legal and regulatory as well as the ... within their designated Hemophilia Therapy Area and for relevant in-line and new product commercialization assets (3 years prior to launch). They will lead the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Oncology Business Unit/US Oncology Business Division (including, for example, Medical Affairs , Sales, Marketing, Market Access, etc.) including, but not limited to, ... areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside...counsel and direction to other members of the Legal Affairs Department as well as serving as a mentor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to, areas of GPO/PBM and trade/distribution agreements, Medicare, Medicaid, product pricing, and government price reporting. Coordination with, and appropriate ... counsel and direction to other members of the Legal Affairs Department as well as serving as a mentor...serving as a mentor in order to foster their professional growth and development as well as their achievement… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relationships include working with Headquarters, NA CMR including Clinical Trial Management, Medical Affairs , Regulatory Affairs and other NNI skill areas. ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Merck & Co. (Rahway, NJ)
- …Work effectively with cross-functional partners including research and development, medical affairs , regulatory affairs , manufacturing, Business Development ... team, Key Opinion Leader engagement execution, competitive strategy, target product profile development, health authority interactions, global regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technologies/ Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of ... at key governance meetings whereby GCLP/GLP activities are being discussed ( Regulatory affairs , Research unit LT, GRDC etc.,) Effectively interacts… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Internally, they may partner with the Local and Global Clinical Operations, regulatory affairs , medical affairs , legal, communications, compliance, etc. ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
