- Lumen (Trenton, NJ)
- …standards that govern our business conduct. Our team is seeking a full-time Lead Corporate Investigator to conduct internal investigations into concerns ... investigations, and will otherwise support the Ethics and Compliance team. The Corporate Investigator role in the organization is critical to the success of the… more
- Merck (Trenton, NJ)
- …and goals for approved, in-development, and active Company-sponsored trials and/or investigator -sponsored research studies and serve as a role model for other ... and/or sharing of therapeutic expertise. Consistent adherence to field and corporate policies and Global Medical Scientific Affairs (GMSA) strategy, including field… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …immune disorders. **Summary** This position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage programs, in order ... safety surveillance and risk management in partnership with Product Safety Lead (s), Clinical Safety Physician(s), and cross-functional team in support of benefit… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …May review tables, listings, and figures (TLF) and CSR safety narratives + May lead the development and updates of the Investigator 's Brochure (IB): author the ... **Clinical Development Expertise Strategy:** + In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the… more
- Sanofi Group (Bridgewater, NJ)
- …treat, providing hope to patients and their families. **Main Responsbilities** + Lead the development of an Integrated Medical Plan (MSLs, IME, Medical ... approval of promotional material and medical materials in compliance with corporate standards and government/industry regulations. + Provide medical and scientific… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …Regulatory Writing and Submission Support, _Oncology and Marketed Products_ . Team lead , based in Cambridge, MA/Virtual. Here, you will be a vital contributor ... Investigational New Drug Applications (INDs), Clinical Trial Applications (CTAs), Investigator 's Brochures (IBs), New Drug Applications (NDAs), Biologic License… more
- Merck (Trenton, NJ)
- …execution of scientific & medical affairs plans for Ophthalmology). They build and lead a team of TA dedicated global and regional directors and associate directors. ... data generation studies with V&I Outcomes Research + Supports the Investigator -Initiated Study program + Leads talent review process and demonstrates follow-through… more