- 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
- BeOne Medicines (Emeryville, CA)
- …or health-related discipline, with at least 12+ years of experience in regulatory affairs , in advertising/promotion, labeling or related discipline + and ... medical affairs , and marketing. + Provide advice on healthcare regulatory matters across business functions, including commercial, clinical development, medical … 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
- 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
- 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
- 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
- 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
- Merck & Co. (North Wales, PA)
- …integrating state-of-the-art technology and applying rigorous scientific and ethical standards.The Senior Director ( Senior Principal Scientist) has primary ... development (pre-clinical to post-licensure). With a focus on late-stage development, the Senior Director will manage the entire cycle of clinical development,… 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
- 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
- CSL Behring (King Of Prussia, PA)
- As the Senior Director , Medical Affairs , you will lead the development and execution of Medical Affairs strategies and tactics to support the assigned US ... fields + Review and approve medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs , and Commercial + Represent US Medical… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director , Regulatory Affairs will be responsible for developing, implementing, and advising on North America (NA) regulatory ... and registration strategies within the US and Canada. The Director will also provide line management, people development, and...candidates will have experience working as a lead in Regulatory Affairs with the FDA and prior… more
- ITG Brands (Greensboro, NC)
- State Government Affairs Director **Location** North Carolina **City** Greensboro **Role Type** Permanent **WHO WE ARE** ITG Brands is the third-largest tobacco ... - JOB SUMMARY Responsible for leading Company's state government affairs strategy across a designated region of the United...regulators, and other stakeholders who shape the legislative and regulatory environment. The Director will serve as… more
- GRAIL (Washington, DC)
- …alliances that drive meaningful change in US health policy. Reporting to the Senior Vice President of Government Affairs and Alliance Development, this ... information, please visit grail.com . GRAIL is seeking a seasoned federal government affairs leader to shape and execute our engagement strategy in Washington, DC… more
