- J&J Family of Companies (Atlanta, GA)
- …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 (Atlanta, GA)
- …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 (Atlanta, GA)
- …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