- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA ... technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements… more
- J&J Family of Companies (Horsham, PA)
- …humanity. Learn more at https://www.jnj.com** **The Medical Director (MD), Medical Affairs , Prostate Cancer** **will serve as a clinical subject matter ... **Identify new key opinion leaders (KOLs) and develop strong KOL collaborations on clinical trial development and medical affairs activities. Represent medical … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience with ex-US labeling… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- Regeneron Cell Medicine is looking for an Associate Director in Regulatory CMC for biologics who will be responsible for the development and submission of ... Regulatory Project Management & Program management, and external cross functional teams, Clinical , non- clinical and regulatory leadership. + Drive adherence to… more
- Grifols Shared Services North America, Inc (Fort Worth, TX)
- …2 years of experience. **Pay Scale:** The estimated pay scale for the Medical Affairs Scientific Director 2 role based in the United States (non-California), is ... area expert for internal and external stakeholders. Provides expert clinical and scientific support to internal teams in the...**For California:** The estimated pay scale for the Medical Affairs Scientific Director 2 role based in… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of a CDx study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after ... to external diagnostic business partners specifically: + Use of CTA/CDx within clinical trials + Device protocols and SAPs + Device non-significant/significant risk… more
- Merck (Rahway, NJ)
- …and recognized scientific expertise (lung cancer) + Extensive experience in medical affairs or clinical development + Strong prioritization and decision-making ... **Job Description** The Executive Director , Value & Implementation (V&I), Global Medical and...+ At least 5 years global or US medical affairs or clinical development experience with proven… more
- NYU Rory Meyers College of Nursing (New York, NY)
- …Academic Affairs at the Silver School of Social Work. Reporting to the Associate Dean, the Director , Academic Affairs will direct complex administrative ... encouraged to apply at all levels. Share this job (https://uscareers-nyu.icims.com/jobs/14564/ director %2c-academic- affairs /job?mode=apply&apply=yes&in\_iframe=1&hashed=-336115631) Need help finding the right job?… more
- Veterans Affairs, Veterans Health Administration (Boston, MA)
- …Telephone and video care are encouraged. Each physician is assigned a registered nurse, clinical associate , and scheduler. There is no call, and no weekend or ... oversight of practice management including direct provider supervision, operational issues and clinical performance. The Medical Director will have clinical … more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, Biosimilars, and Small Molecules.Ensure alignment ... with regulatory trends, innovation, and compliance while balancing business benefits and risks. + Lead and Manage Global Submission Activities: Oversee submission planning, authoring, reviewing, and coordination for regulatory filings (eg, BLA, MAA). Identify… more