- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …As a result, this role will need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional ... Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, and… more
- Eisai, Inc (Nutley, NJ)
- …key business processes. Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs and Commercial ... your profile, we want to hear from you.The Medical Director, US Medical Affairs provides medical leadership for medical affairs strategy, planning and supportive… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …program and content, and field alignment directors. They will also be the senior strategic representative of medical affairs in the relevant therapy area ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...& evidence team and other relevant functions As a senior level representative of medical affairs , the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …activities and ways of working. This role will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define DS' priorities, strategy and ... MD, JD preferred Experience Qualifications7 or More Years Experience in pharma Regulatory Affairs , with at least 3 years developing regulatory strategies… more
- Aequor (Thousand Oaks, CA)
- …supplemental drug applications/biologics license applications is strongly preferred Experience with regulatory documents in Regulatory Affairs , Research, ... FULLY REMOTE Regulatory Writing Senior Manager ln this vital role role you will serve as the functional area lead on product teams, lead writing activities for… more
- Eisai, Inc (Nutley, NJ)
- …hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics mainly for GU therapeutic area. This ... working with key stakeholders to develop and execute the medical affairs plan, including data generations (including RWE), post-marketing research, medical… more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the Product Material Review Team (PMRT) with the Legal, and Medical Affairs departments, ensuring consistency of materials across brands and departments, adherence ... cross functional assistance for PGC, Learning Management System (LMS) and Regulatory , as needed. ResponsibilitiesEditorial Review of Materials Review and consult… more
- Merck & Co. (North Wales, PA)
- …divestment and product withdrawal.Support new technology development.Demonstrate an understanding of regulatory affairs and applies this understanding to the ... Job DescriptionUnder general supervision of an Executive Director/ Senior Director, the Principal Scientist /Director is responsible for developing and implementing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including veterans and people with disabilities.SummaryThis position leads the Global Regulatory Affairs (GRA) Global Labeling function, combining knowledge of ... 10 or More Years pharmaceutical industry experience required- 10 or More Years regulatory affairs experience, including direct experience with CCDS, US and and… more
- Merck & Co. (Rahway, NJ)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May… more
- Aequor (Thousand Oaks, CA)
- …time. Ideal candidate: In need of 5-8 YOE in project management within R&D and regulatory affairs , within pharmaceutical. Not a tech expert but they need to ... Project Manager - End to End Regulatory Content Automation Initiative, Global Regulatory Affairs and Strategy, Position Summary: We are seeking a seasoned… more
- Catalent (San Diego, CA)
- …food or relevant industry with at least 5 years' experience in QA/ Regulatory Affairs areas with progressive responsibilities for quality metrics, quality ... Senior Manager, Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies… more
- Eisai, Inc (Nutley, NJ)
- …be primarily responsible for providing counsel specific to Eisai's pharmaceutical regulatory needs, including sales and marketing, scientific exchange and other ... medical matters relating to assigned products, including promotional and medical affairs materials, labeling, sales training and media/digital materials. Works to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Eisai, Inc (Nutley, NJ)
- …Functions Medical Affairs Strategic Plans: Under the direction of the Senior Medical Director, work with key stakeholders, management, and functional area leads ... for assigned therapeutic area. Under the direction of the Senior Medical Director, this role will be responsible for...Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Operations, Paid Media, Medical, Managed Markets, Corporate Communications and Public Affairs , Regulatory , Privacy, Sales, and Legal. Will also interact ... content management functions for all NNI internet sites Manage PRB (medical, legal, regulatory ) review of NNI internet site and its waterfall of content Manage… 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 ... and resource strategies within a VP Functional area of Clinical Development, Medical & Regulatory Affairs Works with business partners inside and outside of CMR… more
- Arthrex (Naples, FL)
- …Arthrex is actively searching for a Sr. Project Manager, Program Manager - Regulatory Affairs who is responsible for managing and resolving issues related ... Manages subsidiary-based and global projects/programs within the scope of the Regulatory Affairs . Develops project objectives by reviewing project proposals… more
