- Merck & Co. (North Wales, PA)
- …corporate standards and policies and business objectives.Actively participate in labeling and global regulatory team meetings to ensure support for anticipated ... all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, efficient, ... submissions, as appropriate, and corresponding therapeutic dossiers.Interacting with global regulatory authorities and diagnostic partners to determine… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides ... activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory...US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …key internal relationships include global and US stakeholders in other areas of Regulatory Affairs , as well as those who are part of the promotional review ... for a living. Are you ready to make a difference? The PositionThe Regulatory Affairs Therapeutic Area Postdoctoral Fellowship is a one-year, experiential program… more
- BioSpace (Boston, MA)
- … Operations at Takeda will be responsible for formulating and implementing the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy to ... all regulatory sites/functions. Serve as a member of the Global Regulatory Affairs Leadership Team, influencing the operations and future strategy of… more
- Takeda Pharmaceutical (Boston, MA)
- … Operations at Takeda will be responsible for formulating and implementing the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy to ... all regulatory sites/functions. Serve as a member of the Global Regulatory Affairs Leadership Team, influencing the operations and future strategy of… more
- Merck & Co. (North Wales, PA)
- …in collaboration with the CSRM physician.Manage and prepare strategies for regulatory documents and responses to safety inquiries from healthcare professionals, ... regulatory agencies, subsidiary staff and other internal customers in...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionHealth Systems Oncology Medical Affairs Director, US Medical Affairs - NorCal, NV, AZThe Health Systems Oncology Medical Affairs Director (HSO ... in a balanced and credible manner consistent with the regulatory environment and company's ethical standards. This role also...role also serves as a resource for the Medical Affairs (MA) management team on strategic planning and provides… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development and Outcomes Research Marketing and Market development, as well as Global Medical Affairs . Essential Functions Lead projects, representing Medical ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Affairs interests on cross-functional teams including, Field Medical Affairs , Medical Operations , Clinical Trial Management, HEOR,… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPrincipal Scientist / Director, GLOBAL REGULATORY CMC Biologics (R5)Under general supervision of an Executive Director/Senior Director, the ... Document for projects of increasing complexity.Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change… more
- Merck & Co. (North Wales, PA)
- … Medical and Value Capabilities (GMVC). This function exists within the broader V&I Global Medical & Scientific Affairs (GMSA), which is part of Our Company ... Job DescriptionRole Summary The Senior Specialist Global Professional Engagement is a member of the...professional and medical societies) that are in alignment with regulatory body governance and country-specific guidance, with the objective… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sales, marketing, medical affairs , market access and policy/advocacy (MAPA), regulatory affairs , and other relevant NNI departments to ensure alignment ... marketing promotion. Act as a liaison between marketing, medical affairs , and market access. This role will have direct...commercial operations required. Experience with local and global operations preferred Strong knowledge of the… more
- Merck & Co. (North Wales, PA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Global HQ. Key internal relationships include Field Medical Affairs , Medical Strategy & Operations , Medical Information, Publications, Clinical ... Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. Position is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the ... leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety...for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Division of the Company (including, for example, Market Access, Sales, Marketing, Medical Affairs ) as well as DSI employees performing Global roles in the ... the primary legal advisor for the commercial business and operations supporting US approved (or to be approved) oncology...United States (such as Global Marketing, Global Medical Affairs ). For these areas, acts… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relationships include Strategic Operations (focus on Patient Safety), NNI Medical Affairs , Global Medical Affairs , Health Economics Outcomes Research & ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...CMR, Global Information & Analysis (GLIA), and global and affiliate medical affairs colleagues and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strong relationships with internal teams, including Sales, Commercial Excellence, R&D, Medical Affairs , Regulatory Affairs , Market Access, Legal and ... Hemoglobinopathies TA influencing cross-functional members including Market Access, Medical Affairs , Commercial Operations , Finance, etc. Owns the Therapeutic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …market access, commercial effectiveness, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... organization to guide enterprise-wide resource allocations, investment choices, drive core operations and develop insights to drive growth and operational excellence… more
