Job Description

Direct message the job poster from Tucker Parker Smith Group (TPS Group) Professional Recruiter | Matching Talent with Opportunity at TPS Group Senior Medical Writer Location: Remote (US-based, EST or PST hours) Pay Rate: $69$70/hour About the Role Were 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), Investigators 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: Bachelors 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.) #J-18808-Ljbffr Tucker Parker Smith Group

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