- 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 ... registration and life cycle support and the leadership of regulatory strategy for projects that are currently US...preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional… 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 ... person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer...CMC post approval changes, providing regulatory impact assessments, and coordinating with regional RA-CMC leaders… 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)
- …experience in Regulatory Affairs , with hands-on experience in regulatory submissions across multiple regions ( US , EU, and/or other international ... prepared by other technical functions and will act as the primary regulatory contact for the US FDA. The GRL will be accountable for regulatory submissions,… 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 ... application of regulatory science and strong communication and analytical skills. Our Regulatory Affairs team bring new medical advancements to the world by… more
- Insmed Incorporated (NJ)
- …in IT with focus on healthcare/pharmaceutical industryExperience with medical affairs processes and regulatory environmentsStrong technical knowledge of ... values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for five consecutive… 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 ... person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer...vision. This position will report directly to the Executive Director of Medical Affairs . Together with the… more
- Genmab (NJ)
- …dynamic and collaborative setting.The Director , HEOL Team Lead is part of the US Field Medical Affairs leadership team responsible for the execution of the ... Medical Affairs strategy in support of the US business objectives. The Director , HEOL Team...knowledge and adherence to corporate complianceCurrent working knowledge of US -specific legal, regulatory , and compliance regulations and… 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...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… 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
- Eisai, Inc (Nutley, NJ)
- …that drives optimal access and utilization of Eisai marketed products in the United States .Provide input to the health economics and outcomes research ... your profile, we want to hear from you. The Director , US HEOR and RWE (field) is...the employment eligibility of all new hires in the United States . Please click on the following… more
- Merck & Co. (North Wales, PA)
- …Oncology, Patient Advocacy, Patient Insights, Pharmaceutical Industry, Pharmaceutical Medical Affairs , Relationship Management, US Regulatory ... knowledge of best practices in those areasU.S./Global experience in clinical research, regulatory affairs , scientific and medical affairs , or pharmaceutical… 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, ... values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive… more
- Eisai, Inc (Dallas, TX)
- …employers to electronically verify the employment eligibility of all new hires in the United States . Please click on the following link for more information: ... 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… 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 ... values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive… more
- Insmed Incorporated (NJ)
- …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
- 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
- Insmed Incorporated (NJ)
- …cross-functional partners, including ex- US colleaguesWork closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, and Commercial ... of science, we're in. Are you?About the Role:The Senior Director , Head of US HCP Marketing for...Affairs , and Commercial Effectiveness to ensure alignment of US HCP activities with field execution.Partner with Agency of… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
