- Novo Nordisk Inc. (Plainsboro, NJ)
- …overflow in other areas as needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director . Works with personnel in other ... departments including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs . Has a positive approach to work projects and maintains constructive and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Associate Director (AD) is responsible for overseeing all activities ... and is also an integral member of the Medical Affairs Team. This position plays a key role in...data and promotional content within the assigned therapeutic area- Regulatory milestones, actions and guidance relevant to medical review… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …clinical trials is required Demonstrates technical expertise within Clinical Development, Medical Affairs , and Regulatory Affairs (CMR), staying up-to-date ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …focusing on optimizing patient care and support. Relationships Reports to the Director of PSP Analytics and Ops Excellence. Key internal relationships include ... and Reimbursement, Finance, IT, etc. Other internal relationships include Public Affairs and CMR. External relationships include relations with external consultants,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experienceExperience with ex-US ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Merck & Co. (Rahway, NJ)
- …and solutions to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory ... Job DescriptionOur Regulatory Affairs team bring new medical...activities include, but are not limited to:Reports to Executive Director or Associate Vice President, Therapeutic Area… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Liasions to ensure sucessful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents ... globallyCreates a forward-looking Diagnostic development strategy while keeping abreast of regulatory and policy updates in the external environment and by tracking… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA, ... and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global PV Quality teams located in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …statistical results and provide input on reporting (CSR) to support Medical Affairs and HEOR/HTA strategies: Plan, set-up and execute additional statistical analyses ... Statistical deliverables. Contribute, with limited supervision, to documents submitted to Regulatory or Pricing Authorities. May participate as subject matter expert… more
- Insmed Incorporated (Bridgewater, NJ)
- …in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HCP Marketing will be a key member of the ... our culture. This position will report to the Senior Director , HCP and Payer Lead. This position does not...and media agencyWork closely with cross-functional partners including Legal, Regulatory , Compliance, and Medical Affairs , to align… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and resource strategies for a VP Function of the Clinical Development, Medical & Regulatory Affairs (CMR) Business Unit. The ideal candidate will possess a ... of best practices. Relationships The Manager, reports to the Director , CMR Business Planning & Strategy. The incumbent works...a VP Functional area of Clinical Development, Medical & Regulatory Affairs Works with business partners inside… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Strategy Pleasanton, CA, USA * Princeton, NJ, USA Req #374 Thursday, May 30, 2024 Looking for a chance to make a ... and/or development regulatory activities under the direction of Regulatory Affairs management. The incumbent plans, directs and executes the regulatory… more
- Novo Nordisk (Princeton, NJ)
- …changing lives for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will ... strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions +… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will ... mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities… more
- Ascendis Pharma (Princeton, NJ)
- The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling activities across programs and stages of development, with ... Americas and supporting global needs as required. The RA Associate Director , Labeling will be overall responsible...for regulatory submissions and product maintenance. The Associate Director prioritizes their own work to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs ** + Location: Bridgewater, NJ or Cambridge, MA **About the job** ... The Associate Director , US Advertising and Promotion serves...Rare Blood Disorder and Neurology portfolio. As the RC Regulatory Affairs representative, work with brands on… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs ** + Location: Cambridge, MA or Bridgewater, NJ **About the job** ... The Associate Director , US Advertising and Promotion serves...The Associate Director , US Advertising and Promotion serves as the ... lead on Review Committees (RCs). As the RC Regulatory Affairs representative, work with brands on… more
- Novo Nordisk (Plainsboro, NJ)
- …Relationships Report to the Director / Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain positive ... Position Manage and oversee all assigned projects/products/processes. Assist the Director / Associate Director in assuring Novo...rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and… more
