- Novo Nordisk Inc. (New York, NY)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you.Job Summary The Director is responsible for developing strategies for assigned product(s) and execution of HEOR and ... products, interfaces with cross-functional teams including marketing, market access, and medical affairs to align strategies, and partners with HEOR field team in… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The 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 will include… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** The Director , Regulatory Affairs , Specimen Management reports directly to the VP Regulatory Affairs , Specimen Management. ... This position is responsible for the Specimen Management Regulatory Affairs operations and strategy ...registrations, sustaining support, and regulatory advocacy. The Director , Regulatory Affairs , Specimen Management… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), may be called ... practical, workable plans to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical also works directly with… more
- New York State Energy Research and Development Aut (New York, NY)
- …senior attorney (the "MD-L&R") to join its management team, lead its Legal & Regulatory Affairs ("LRA") team and provide legal advice and strategic counsel with ... for overseeing and being directly responsible for a variety of legal and regulatory affairs activities and deliverables at the highest level of industry… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Regeneron's vibrant pipeline in the area of general medicine within the Regulatory Strategy group in Regulatory Affairs . The incumbent will lead a group ... regulatory strategies for product development. This management position in Regulatory Affairs involves the ability to lead and manage a Therapeutic Area (TA)… more
- Pfizer (New York, NY)
- **ROLE SUMMARY** The Director , Medical Affairs Oncology Digital & AI Innovation will report to the Oncology AI Innovation Head. This is a vital role within the ... and transform cancer patients' outcomes. **DIGITAL RESPONSIBILITIES** + Lead Digital solution strategy for Oncology medical affairs . + Optimize budget spend,… more
- Cypress Creek Renewables (New York, NY)
- Associate Director , State Affairs (East) at Cypress Creek Renewables (View all jobs) (https://ccrenew.com/careers/) New York or East Coast Remote The Company ... have a strong energy background, and experience with policy development, regulatory /legislative analysis, drafting, political strategy , and coalition building… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** Reporting to the Director or Executive Director in Organon Regulatory CMC New Products, the Associate Principal ... Scientist (Associate Director ) is responsible for Regulatory Chemistry Manufacturing...leading preparation and authorship of applicable IND/CTAs, Health Authority Regulatory CMC engagement strategy , Agency Background Packages,… more
- Pfizer (New York, NY)
- …Team, Medical Sub Committee, Clinical Study Teams, Asset Team, Program Teams, and Regulatory Strategy teams as applicable. Contributes to discussions to ensure ... regulatory inspections and audits. In collaboration with the Clinical Affairs Lead and Medical/Scientific Lead, prepares strategy decisions, presents and… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …with leadership within Biostatistics and Data Management, Clinical Sciences, Regulatory Affairs , Development Operations and Development Program Management, ... The Executive Director , Biostatistics (CDU-Biostatistics Head, Internal Medicine) leads the...the industry, and work with company to develop a regulatory strategy to address statistical needs. +… more
- Capital One (New York, NY)
- …Finance, CRA Strategy and Program Management, the Government and Political Affairs Group, Regulatory Relations, and Strategy and Engagement. Through ... New York Director , Community Finance - Capital Officer **Overview:** External Affairs works with many external and internal stakeholders to envision and create a… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …1 and phase 2A for the company, drawing on expertise in clinical and regulatory strategy and requirements, both local and international, related to the clinical ... stages of development. + Collaborate with KOLs as needed to for clinical/ regulatory strategy , Health Authority Advisory meetings, development of target… more
- Pfizer (New York, NY)
- …& asset leaders from R&D, Portfolio Management, CMAO, Medical Affairs Strategy , Biostatistics & Data Management, Global Regulatory Affairs , Clinical ... **ROLE SUMMARY** **The Platform:** The Chief Medical Affairs Office's Real World Evidence (RWE) Platform is...critical role in the development of a comprehensive RWE strategy , tactical plans, and projects that meet research and… more
- Edwards Lifesciences (Stamford, CT)
- …company, specifically but not limited to Operations, Finance, Marketing, Human Resources, R&D, Regulatory Affairs , Medical Affairs , and Clinical Affairs ... be part of our inspiring journey. As a Regional Director , you will lead commercialization and expansion of groundbreaking...and Field Clinical Specialists). **_This position will drive sales strategy and manage a team based out of New… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business development functions. MTPA is dedicated to ... As a senior member of Clinical Operations, the Senior Director , Clinical Operations will lead the full development team...for the company, drawing on expertise in clinical and regulatory requirements, both local and international, related to the… more
- AbbVie (Newark, NJ)
- …Clinical, Regulatory , Biostatistics, Regulatory Policy & Intelligence, Government Affairs , and Market Access teams. The Associate Director will support ... on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Patient Experience Data (PED) Policy & Best Practices, is responsible… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …PK analysis plans, study reports, and Clinical Pharmacology sections of regulatory submissions. The Senior Director , Clinical Pharmacology also analyzes, ... 2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business development functions. MTPA is dedicated to… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …the clinical medicine and drug development processes. He/she will lead The Senior Director , MSLS will be responsible for MSLS strategy , clinical program ... 2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business development functions. MTPA is dedicated to… more
