Sr. Medical Writer Job at TPS Group Company in San Rafael

Senior Medical Writer

Location: Remote (US-based, EST or PST hours)

Pay Rate: $69-$70/hour

6-month contract (potential to extend or convert)

bout 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.)