- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and ... preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional experience in the biopharmaceutical… more
- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs , CMC will be responsible for reviewing the ... CMC post approval changes, providing regulatory impact assessments, and coordinating with regional RA-CMC leaders to formulate regulatory strategies for… more
- Merck & Co. (Rahway, NJ)
- … Regulatory Affairs & Clinical Safety (GRACS) - The Associate Director of Regulatory Submissions Archive Operations serves as the Business System Owner ... Management, Employee Training Programs, FDA Regulations, Life Science, Pharmaceutical Regulatory Affairs , Pharmacovigilance, Policy Implementation, Regulatory… more
- Insmed Incorporated (NJ)
- …degree (MS, PhD, PharmD) strongly preferredMinimum of 5 years of experience in Regulatory Affairs , with hands-on experience in regulatory submissions across ... for the future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing global … more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Director , Regulatory Affairs , supports products in the Oncology therapeutic area as part of a regulatory team.- The ... regulatory science and strong communication and analytical skills. Our Regulatory Affairs team bring new medical advancements to the world by facilitating… more
- Insmed Incorporated (NJ)
- …in IT with focus on healthcare/pharmaceutical industryExperience with medical affairs processes and regulatory environmentsStrong technical knowledge of ... science, we're in. Are you?About the Role:The IT Business Partner for Medical Affairs and Innovation serves as a strategic liaison between Information Technology and… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Medical Director , Medical Affairs - Dermatology role will be responsible for supporting the ... Affairs strategic vision. This position will report directly to the Executive Director of Medical Affairs . Together with the Executive Director of… more
- Merck & Co. (Rahway, NJ)
- …of experience in global patient advocacy and engagement activitiesUS/global experience in regulatory affairs , medical and scientific affairs , and ... Job DescriptionThe Executive Director and Global Lead, Patient Advocacy & Strategic...Implementation (V&I) organization, which includes Global Medical and Scientific Affairs as well as Outcomes Research. This position executes… more
- Merck & Co. (North Wales, PA)
- …knowledge of best practices in those areasU.S./Global experience in clinical research, regulatory affairs , scientific and medical affairs , or pharmaceutical ... Oncology, Patient Advocacy, Patient Insights, Pharmaceutical Industry, Pharmaceutical Medical Affairs , Relationship Management, US Regulatory AffairsPreferred Skills:… more
- Novo Nordisk Inc. (Seattle, WA)
- 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Insmed Incorporated (NJ)
- …and regulatory review.With Medical Excellence, lead training of Medical Affairs teams on new materials and upcoming educational activities.Ensure delivery of ... future of science, we're in. Are you?About the Role:We're looking for a Director , Scientific Communications on the Medical Strategy and Communications team to help… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director … more
- Merck & Co. (Rahway, NJ)
- …Office (PMO); and Administrative Professionals. Position Description/Summary: The GPAM Associate Director , Value & Implementation Project Manager (VIPM), is a core ... progress the R&D pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive cross-functional… more
- Insmed Incorporated (NJ)
- …team, partnering closely with heads of clinical operations, toxicology, regulatory affairs , commercial, pharmacovigilance, clinical quality, and ... we're in. Are you?About the Role:We're looking for an Executive Medical Director of Ophthalmology, Clinical Development to help us expand what's possible for… more
- Eisai, Inc (Dallas, TX)
- …If this is your profile, we want to hear from you. The Associate Director , Access and Reimbursement (AD ARM) will lead the Eisai Access and Reimbursement Managers ... Markets, Market Access and Reimbursement Services, Sales, Marketing, Government Affairs , Legal, Compliance, Medical, and Training. Ultimately, this individual will… more
- Insmed Incorporated (San Diego, CA)
- …will provide clinical and scientific support to clinical development and operations, regulatory , medical affairs , drug safety, and quality assurance teams, as ... the future of science, we're in. Are you?About the Role:We're looking for a Director , Clinical Scientist for the Gene Therapy Clinical Development team to help us… more
- Genmab (NJ)
- …fit? Then we would love to have you join us!The RoleGenmab is currently seeking a Director , HEOL (Health Evidence and Outcomes Liaison) Team Lead to be a part of an ... exciting, passionate, high profile, high impact Medical Affairs team, and work in a highly dynamic and...and work in a highly dynamic and collaborative setting.The Director , HEOL Team Lead is part of the US… more
- Insmed Incorporated (NJ)
- …submission trackers, and regulatory archives.Partner with cross-functional teams ( Regulatory Affairs , CMC, Clinical, Quality) to facilitate document ... what's possible for patients with serious diseases. Reporting to the Executive Director , Regulatory Operations, you'll be responsible for the publishing,… more
- Insmed Incorporated (NJ)
- …E xpert knowledge of relevant guidelines including, but not limited to medical and regulatory affairs , drug development, FDA and regulatory guidelines (ie, ... 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 medical… more
- Merck & Co. (Rahway, NJ)
- …communications.Stakeholder Collaboration: Work closely with cross-functional teams (medical affairs , communications, regulatory , GEMs etc.) to ensure ... and Reporting: Ensure all activities adhere to relevant legal, regulatory , and ethical standards. Maintain accurate documentation and generate reports… more
