Tucker Parker Smith Group (TPS Group)
Senior Medical Writer
Tucker Parker Smith Group (TPS Group), Novato, California, United States, 94949
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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 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.)
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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 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.)
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