- Bristol Myers Squibb (Princeton, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . The US Medical Director , Cell Therapy, Rheumatology is a core member of the Cell Therapy, ... engagement with US Rheumatology leaders and represent Cell Therapy Medical Affairs in key US commercialization decisions. **Key Responsibilities:** + Therapeutic… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical ... unless the accommodation would impose undue hardship on the operation of the Company's business . For roles in which the hired candidate will be working in the US,… more
- Bristol Myers Squibb (Princeton, NJ)
- …other forums). + Supports the successful evolution of Global Medical's business model by developing and implementing strategic communications that inform colleagues ... Impact Agenda, and critical role in successfully executing Commercialization business plans (Medical Evidence Generation; Commercialization Model; Product launches;… more
- Bristol Myers Squibb (Princeton, NJ)
- …the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ability to ... as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid… more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . The Worldwide (WW) Medical Director for Cell Therapy in Lupus is a core member and leader ... and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …(IEP) across the US Medical Teams, and in conjunction with the Daiichi Sankyo US Business , and the Daiichi Sankyo Global IEP network. - Lead the design and execution ... discussions are informative, motivating, and translatable to the Daiichi Sankyo US Business division. This includes but is not limited to analyzing results… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …cross-functional teams (eg, Diagnostic Development Teams) and to external diagnostic business partners specifically: + Use of CTA/CDx within clinical trials + ... Device protocols and SAPs + Device non-significant/significant risk determinations (both submission to CDRH in a Q-sub process and in a streamlined fashion within protocol submission to CDER via the INDs), IDEs + Biomarker strategies towards patient selection,… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …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 required documentation and ensure timely, high-quality submissions meeting global requirements. + Health Authority Interactions and… more
- Merck (Rahway, NJ)
- **Job Description** The US Regional Director /Principal Scientist Medical Affairs (RDMA) is responsible for driving execution of the Value and Implementation ... They are impactful members of regional cross-functional teams, including Global Medical Affairs (GMAT), US Commercial, Value Team, Policy and Market Access. They… more
- MTF (Edison, NJ)
- …tissue donors, and their families through our guiding principles. The VP Medical Affairs leads medical affairs for the organization and is responsible for ... on donor infectious disease transmission risk, and associate medical director supervision for donor eligibility determination. **Responsibilities** + The VP… more