- 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
- Eisai, Inc (Nutley, NJ)
- …consider remote based.Eisai Salary Transparency Language:The annual base salary range for the Director , Global Regulatory Affairs , Growth Markets is from ... broad pharmaceutical industry experience, including 8 years of direct Regulatory Affairs experience with new/innovative drug registration...the employment eligibility of all new hires in the United States . Please click on the following… 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 US Director of Medical Affairs (DMA) for Gynecologic Malignancies (Ovarian, Endometrial and Cervical Cancer) holds primary responsibility ... Primary activities include, but are not limited to :Develops and executes US Medical Affairs strategy for Gynecologic malignanciesDrives creation and… 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
- Eisai, Inc (Philadelphia, PA)
- …implement recommendations for resolution.Certification is a plus (such as Regulatory Affairs Professional Society (RAPS)Technical Skills RequiredAdvance working ... and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will collaborate...the employment eligibility of all new hires in the United States . Please click on the following… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- … affairs , market access and policy/advocacy (MAPA), Global Commercial, regulatory affairs , other relevant NNI departments. Essential Functions Identify, ... team culture that is made up of diverse skillsets, united by the shared belief that reinvention and learning...pull you in? Are you ready to experiment with us ? The Position The Director , Key Opinion… 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
- Merck & Co. (Rahway, NJ)
- …with cross-functional teams, including research, development, quality control, and regulatory affairs , to ensure comprehensive biophysical characterization of ... Biology, Process Analytical Technology (PAT), Professional Networking, Quality Control Management, Regulatory Affairs Compliance, Regulatory Compliance, … 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)
- …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 (Shreveport, LA)
- …employers to electronically verify the employment eligibility of all new hires in the United States . Please click on the following link for more information: ... profile, we want to hear from you. The Associate Director / Director , MSLs is responsible for the leadership,...in the region and works collaboratively with the Medical Affairs Senior management with strategic and tactical planning, working… more
- Insmed Incorporated (NJ)
- …team, partnering closely with heads of clinical operations, toxicology, regulatory affairs , commercial, pharmacovigilance, clinical quality, and ... science, 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… 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 ... 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
- 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
