- Integra LifeSciences (Princeton, NJ)
- …what's possible and making headway to help improve outcomes. The Quality Compliance Technical Writer will work with Quality system leadership and cross ... documentation and responses in support of regulatory compliance correspondence. The Quality Compliance Technical Writer will serve as primary writer for… more
- J&J Family of Companies (Trenton, NJ)
- …practices across R&D. Principal Responsibilities: Leadership: + With a focus on clinical scientific content, lead early strategic submission discussions in ... The Director, Regulatory Medical Writing (RegMW) is a highly experienced medical writer and influential leader with strategic responsibilities as it relates to the… more
- J&J Family of Companies (Trenton, NJ)
- …some mentorship from functional management and clinical team, as needed. + If a lead writer for a program: Be the primary point of contact and champion for ... Authoring experience with investigator brochures, clinical study protocols, and clinical study reports. Experience with common technical document summaries… 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 ... such as Briefing Books (BB), Investigational New Drug Applications (INDs), Clinical Trial Applications (CTAs), Investigator's Brochures (IBs), New Drug Applications… more