- 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
- Novo Nordisk Inc. (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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Director , Medical Affairs Omnichannel Engagement, role is to support the ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...the medical affairs omnichannel engagement strategy. The Associate Director - MOE will work with one… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing ... Regulatory guidelines and assists in educating the organization on evolving Regulatory Affairs CMC (RACMC) issues and regulations through internal technical… 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …escalates performance issues and training-needs to CRA (Clinical Research Associate ) manager and/or functional vendor and internal management as-needed.Performs ... as needed different challenges and issues to TA Head/CRD Clinical Research Director /CCQM Country Clinical Quality Manager and or CTT Clinical Trial Team-(as… 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)
- …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
- Merck (Rahway, NJ)
- **Job Description** **Position Description:** ** Associate Director , Regulatory Affairs Liaison- Vaccines and Infectious Disease** The Regulatory ... the Vaccine and Infectious Disease (VID) therapeutic area as part of a regulatory team. They will have excellent communication and collaboration skills and will work… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... + Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience authoring and/or implementing processes. +… more
- Organon & Co. (Jersey City, NJ)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... **Job Description** **The Position** The Associate Principal Scientist is responsible for developing and implementing Regulatory Chemistry, Manufacturing and… 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
