- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs , Regulatory Strategy to ... be a part of our Global Regulatory Affairs organization.In this role, you will...on a compound in late-stage development to implement the US regulatory strategy for multiple new indications.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …leader will be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA ... accountable for ensuring consistent and transparent ways of working across the Alliance within US regulatory affairs and will work closely with the US … more
- Genmab (Plainsboro, NJ)
- …looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory leader will be ... per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy, Global Regulatory Affairs ,...health authorities as appropriate Monitor and assess global and US regulatory guidelines and regulations and current… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... the company's growth, thereby accomplishing corporate goals.Responsibilities:Develop and implement US regulatory strategy for assigned project(s). Strategize and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …More Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience ... US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI,… more
- Merck & Co. (North Wales, PA)
- …of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional practices ... Job DescriptionReports to the Director /Senior Director in the Office of...regulatory consultation in the development and implementation of US marketing strategy and promotional programsSupport the US… more
- Merck & Co. (North Wales, PA)
- …the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a ... Job DescriptionThe Regional Director of Medical Affairs (RDMA) for...strategy and interactions with Patient Advocacy GroupsTracks guidelines and regulatory landscape in the US regionReview of… more
- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.The RoleThe Associate Director of US Medical Affairs Solid Tumors Strategy will report ... to the Director , US Medical Affairs Solid Tumors Strategy Lead....through collaboration with US Commercialization, Global Medical Affairs , Clinical Development, Regulatory , and other cross… more
- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.The Role The Director of US Medical Affairs Solid Tumors Strategy will report to ... the Senior Director , US Medical Affairs Solid...through collaboration with US Commercialization, Global Medical Affairs , Clinical Development, Regulatory , and other cross… 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. 30% overnight ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Area in certain instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior… 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 reporting, and publication. - Specifically, the Senior Director may be responsible for Evaluating pre-clinical and translational...in certain states and cities within the United States . Final determinations with respect to… more
- Merck & Co. (Rahway, NJ)
- …effectively and collaborate with internal teams across the organization, including legal, regulatory affairs and senior management to develop strategies and ... Job DescriptionThe Director , Issues Management and Crisis Mitigation is responsible...in certain states and cities within the United States . Final determinations with respect to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …maintaining technical training programs related to GxP, Clinical, Medical and Regulatory affairs , Patient Safety required A thorough understanding and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Merck & Co. (Rahway, NJ)
- …stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive data excellence and enhance the efficiency ... of stakeholders, including medical researchers, veterinarians, project managers, and regulatory affairs professionals, to achieve project goals.Key… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders across Novo Nordisk Inc (NNI) including Clinical Development, Medical, & Regulatory Affairs (CMR), Commercial Strategy & Marketing, and the Global ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Key internal relationships include Project Managers, Clinical Directors, Medical Affairs directors, HEOR Directors, Market Access director ,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... human health starts here and that patients rely on us . We're changing lives for a living. Are you...will report to Senior Director or Executive Director Safety Surveillance, US East Coast Development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Analytics team members, Global commercial and New Product Planning teams, Medical Affairs , Regulatory Affairs , Legal, and Market Access. Collaborates ... development. Are you ready to maximize your potential with us ? The Position As the Associate Director ...with us ? The Position As the Associate Director of Strategic Market Insights, the functional responsibilities include… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... human health starts here and that patients rely on us . Our R&D hub merges biotech speed and agility...external stakeholders. Relationships This position will report to Executive Director - Safety Surveillance, US East Coast Development… more
- Merck & Co. (Rahway, NJ)
- …the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a ... Job DescriptionPrincipal Scientist ( Director ) Outcomes Research - Women's CancerUnder the guidance of a senior leader, the Principal Scientist ( Director ),… more
