Senior Medical Writer - Regulatory & Cross-Functional

Openkrill; United States; Remote; USD 95,000 - 140,000; Full time

Job summary

TransPerfect seeks an organized, motivated Senior Medical Writer to partner across Clinical Development, Regulatory, and Operations. You will plan and prepare high-quality regulatory documents, including protocols, study reports, investigator brochures, and module documents, aligning with client and agency guidelines and tight timelines.

The role emphasizes leadership in timelines, cross-functional coordination, template use, and publishing support.

Qualifications

• 5+ years of medical writing experience in the CRO/biotech/pharmaceutical field.
• Bachelor’s degree or higher in a relevant field.
• Oncology, Infectious Disease, or Vaccine experience desired.
• Experience writing protocols, publications, study reports, investigator brochures, and module documents.

Responsibilities

• Lead the execution of documents, including creating, maintaining, and communicating timelines
• Coordinate cross-functional client contributors and internal resources to ensure timely completion of documents
• Ensure document development adheres to client processes, templates, and instructional documents
• Serve as an expert on client document management system and related tools
• Lead document message development in collaboration with client
• Interpret data and create shell documents to support authoring
• Plan and lead kickoff meetings
• Facilitate resolution of review feedback and plan comment resolution meetings
• Follow-up with team members to resolve outstanding review feedback
• Ensure consistency across client programs in messaging, formatting, and presentation

Skills

Medical writing

Project management

Cross-functional collaboration

Attention to detail

Communication skills

Education

Bachelor’s degree or higher in a relevant field

Tools

MS Word

Document management systems

Collaboration tools

Job description

TransPerfect seeks an organized, motivated Senior Medical Writer to partner across Clinical Development, Regulatory, and Operations. You will plan and prepare high-quality regulatory documents, including protocols, study reports, investigator brochures, and module documents, aligning with client and agency guidelines and tight timelines.

The role emphasizes leadership in timelines, cross-functional coordination, template use, and publishing support.