- Formation Bio (New York, NY)
- …mission to bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for ... preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional experience in the biopharmaceutical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director , Global Oncology Medical Affairs , Medical Analytics will be responsible ... dashboards to communicate key findings and recommendations to internal stakeholders, including senior leadership and medical affairs teams. Ensure utilization of… more
- Merck & Co. (Upper Gwynedd, PA)
- …analysis, regulatory reporting, and publication. -- Responsibilities: Specifically, the Senior Director may be responsible for: -Analyzing and summarizing ... radically changes the way we approach serious diseases. --The Senior Director will report to an Associate...closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director...quality and compliance.Evaluate risks impacting GxP compliance within Medical Affairs , driving ongoing improvements to meet regulatory … more
- Novo Nordisk Inc. (Seattle, WA)
- …for key strategic and priority Managed Markets accounts. Position reports to Field Director / Senior Field Director /Executive Director . Essential Functions ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...to make a difference? The Position Within Field Medical Affairs (FMA), this position has primary responsibility for directing… more
- Merck & Co. (Boston, MA)
- …execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be Responsible For: Evaluating pre-clinical and ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has...closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Senior Director , Medical Services will provide strategic leadership to Insmed's independent ... strategies to fill core educational and research gaps. The Senior Director , Medical Services will drive operational...relevant guidelines including, but not limited to medical and regulatory affairs , drug development, FDA and … more
- Insmed Incorporated (NJ)
- …for each other, and for the future of science, we're in. Are you?About the Role:The Senior Director , Head of US HCP Marketing for our TPIP program in Pulmonary ... tactical execution tailored to each geography.Franchise CollaborationPartner closely with the Senior Director , HCP Marketing Lead (PH-ILD/IPF/PPF) to ensure… more
- Insmed Incorporated (NJ)
- …for each other, and for the future of science, we're in. Are you?About the Role:The Senior Director , Head of US HCP Marketing for our brensocatib program in HS ... Governance, Supply, Global Brand Strategy Team, etc)Work closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, Advocacy, and Commercial… more
- Eisai, Inc (Memphis, TN)
- …of MSLs in the region and works collaboratively with the Medical Affairs Senior management with strategic and tactical planning, working collaboratively ... profile, we want to hear from you. The Associate Director / Director , MSLs is responsible for the leadership,...with Medical Affairs and Clinical Development teams for support of clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the pharmaceutical or biotechnology industry. Relationship This job reports to the Senior Director of the GxP Compliance & Technical Operations or the ... Director , GxP Compliance, Patient Safety, & Vendor Oversight. This...degree in a relevant field (Life Sciences, Quality Assurance, Regulatory Affairs , etc.); advanced degree preferred 7+… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …PA or Somerset, NJ. Role OverviewWe are seeking a highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical safety ... strategy.Collaborate closely with internal functions such as Pharmacology, CMC, Regulatory Affairs , Clinical, and Program Management.Maintain up-to-date… more
- Merck & Co. (North Wales, PA)
- …execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be Responsible For:Evaluating pre-clinical and ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has...closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage… more
- Merck & Co. (South San Francisco, CA)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... development projectsAssist the Senior Director , Associate Vice-President/Vice-President and Product Development Team Lead in ensuring that appropriate corporate… more
- Novo Nordisk Inc. (Omaha, NE)
- …coordination with his/er Field Director . Relationships Position reports to Field Director / Senior Field Director . Serves as organization spokesperson on ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...scientific and clinical education and experience. Within Field Medical Affairs , this position functions as a scientific liaison between… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …technologies to elevate employee performance and growth. Relationship This job reports to the Senior Director of the GxP Compliance & Technical Operations or the ... GxP Compliance, Patient Safety, Vendor Oversight Director . This job will interact with Patient Safety, Quality,...years of experience in pharmaceutical training, clinical research, or regulatory affairs ATD certification a plus Proficient… more
- Stryker (Las Vegas, NV)
- The ** Senior Director , Regulatory Affairs ** is a key strategist, responsible for developing regulatory strategy for the **Endoscopy business unit** ... partnership with business unit leadership, Marketing, R&D, Clinical and Quality teams, the Senior Director and team will develop and advise on product… more
- Penn Medicine (Philadelphia, PA)
- …Street, Philadelphia, PA + Hours: 8hr Days **Summary** : The Senior Corporate Director of Regulatory Affairs for Penn Medicine provides leadership and ... Management and Leadership: Manage and provide leadership to all entity directors of regulatory affairs , ensuring alignment with Penn Medicine goals and … more
- Lilly (Indianapolis, IN)
- …medicines to patients who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will ... for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and...leverage CMC technical knowledge and regulatory science expertise to drive regulatory CMC… more
- Unilever (Austin, TX)
- …we'd love for you to be part of it. **JOB SUMMARY** The Senior Director , Quality Assurance and Regulatory Affairs will lead the company's quality ... assurance, quality control, and regulatory compliance efforts for its dietary supplement products. This role is responsible for developing and executing quality… more
