Senior Medical Writer: Regulatory Docs & Cross-Functional Lead

TransPerfect; United States; Remote; USD 90,000 - 150,000; Full time

Job summary

TransPerfect is seeking an organized, motivated senior medical writer to join our medical writing team in the United States. This role partners cross-functionally with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management to plan and prepare high-quality regulatory documents.

The senior writer will produce protocols, publications, study reports, investigator brochures, narratives, and module documents in line with client and agency guidelines to support

Qualifications

• 5+ years experience as a medical writer in CRO/biotech/pharma.
• Strong ability to manage documents and templates.
• Experience writing protocols, study reports, and regulatory documents.

Responsibilities

• Lead the execution of documents and project timelines.
• Coordinate cross-functional contributors and internal resources to ensure timely completion.
• Ensure adherence to client processes, templates, and instructions.
• Serve as an expert on the client document management system and tools.
• Lead document message development in collaboration with the client.
• Interpret data and create shell documents to support authoring.
• Plan and lead kickoff meetings.
• Facilitate review feedback and resolve comments.
• Maintain consistency across programs in messaging and formatting.
• Conduct literature searches as needed.
• Perform peer QC review as needed.
• Contribute to medical writing operational initiatives if needed.

Skills

Medical writing

Project management

Cross-functional collaboration

Communication skills

Education

Bachelor’s degree or higher in a relevant field

Tools

Microsoft Word

Document management systems

Publishing tools

Job description

TransPerfect is seeking an organized, motivated senior medical writer to join our medical writing team in the United States. This role partners cross-functionally with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management to plan and prepare high-quality regulatory documents.

The senior writer will produce protocols, publications, study reports, investigator brochures, narratives, and module documents in line with client and agency guidelines to support