Tucker Parker Smith Group (TPS Group)
Tucker Parker Smith Group (TPS Group) is hiring: Senior Medical Writer in Novato
Tucker Parker Smith Group (TPS Group), Novato, CA, United States, 94949
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Senior Medical Writer
Location: Remote (US-based, EST or PST hours)
Pay Rate: $69–$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: Protocols, amendments, and informed consent forms, Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), Periodic safety reports (PBRERs, DSURs, etc.), Regulatory submission documents (e.g., briefing books, IND/NDA/BLA/eCTD Modules 2 & 5)
- 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)
- Professional writing certifications (e.g., AMWA, DIA) are a plus
Experience:
- 6+ years of medical writing experience in the pharmaceutical or biotechnology industry
- Direct experience writing and reviewing clinical and regulatory documents (protocols, CSRs, IBs, PBRERs, DSURs, INDs/NDAs/BLAs)
- 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.)