Senior Medical Writer Job at Tucker Parker Smith Group (TPS Group) in Novato

Senior Medical Writer Location: Remote (US-based, EST or PST hours) Duration: 6‑month assignment (potential of extension or conversion) Pay Rate: $65–$70/hour About the Role We’re seeking an experienced Senior Medical Writer to support the preparation of high-quality clinical and regulatory documentation for global drug development programs. The ideal candidate will bring strong scientific understanding, exceptional writing skills, and the ability to manage multiple deliverables in a fast-paced, cross‑functional environment. Key Responsibilities Draft and edit clinical and regulatory documents, including regulatory submission documents (e.g., briefing books, IND/NDA/BLA/eCTD Modules 2 & 5), Protocols, amendments, and informed consent forms, Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), Periodic safety reports (PBRERs, DSURs, etc.) Lead document development, including meeting facilitation, timeline management, and review/adjudication processes Represent Global Medical Writing at study and development team meetings Provide writing and editorial support for related materials (SAPs, CRFs, manuals) Contribute to process improvements and template development for efficient documentation practices Ensure all work complies with ICH, FDA, and EMA standards Qualifications Education: Bachelor’s or higher degree (scientific discipline preferred) Experience: 6+ years of medical writing experience in the pharmaceutical or biotechnology industry Direct experience writing and reviewing clinical and regulatory documents (must have CSR and Mod. 2 summary documentation experience) Strong understanding of clinical development, data presentation, and regulatory requirements Proficient with Microsoft Word, Excel, Adobe Acrobat, PowerPoint, and document management systems (Veeva, SharePoint, etc.) Seniority Level Associate Employment Type Contract Job Function Science and Writing/Editing Industries Biotechnology Research and Pharmaceutical Manufacturing Benefits: Medical insurance, Vision insurance, 401(k) #J-18808-Ljbffr