Senior Medical Writer: Regulatory Documentation Lead

OpenKrill; United States; Remote; USD 110,000 - 150,000; Full time

Job summary

TransPerfect is seeking an organized, motivated senior medical writer to partner with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management. You will lead planning and preparation of high-quality regulatory documents including protocols, publications, study reports, investigator brochures, narratives, and module documents within tight timelines.

The role requires 5+ years of medical writing experience in CRO/biotech/pharmaceutical settings, a Bachelor's

Qualifications

• 5+ years of medical writing experience in CRO/biotech/pharmaceutical settings.
• Experience writing clinical study reports, protocols, amendments, investigator brochures, module 2/5 documents.
• Familiarity with ICH and US regulatory requirements; some ex-US knowledge is a plus.
• Strong command of English writing and verbal communication.

Responsibilities

• Lead the execution of regulatory documents and manage timelines.
• Coordinate cross-functional contributors and internal resources to ensure timely document completion.
• Ensure adherence to client processes, templates, and instructions.
• Serve as an expert on document management systems and related tools.
• Lead document message development in collaboration with clients.
• Plan and lead kickoff meetings and reviews, curate comments for efficient resolution.
• Ensure consistency across programs in messaging, formatting, and presentation.
• Perform literature searches and peer QC as needed.
• Contribute to medical writing operational initiatives as needed.

Skills

Medical writing

Project management

English communication

Team collaboration

Regulatory knowledge

Lean authoring

Education

Bachelor's degree or higher in a relevant field

Tools

Microsoft Word

Document management systems

Review tools

Job description

TransPerfect is seeking an organized, motivated senior medical writer to partner with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management. You will lead planning and preparation of high-quality regulatory documents including protocols, publications, study reports, investigator brochures, narratives, and module documents within tight timelines.

The role requires 5+ years of medical writing experience in CRO/biotech/pharmaceutical settings, a Bachelor's