TPS Group Company
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.)
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.)