Senior Medical Writer: Regulatory Leader & Cross-Functional

TransPerfect; France; On-site; EUR 60,000 - 100,000; Full time

Job summary

TransPerfect is seeking an organized, motivated senior medical writer to partner cross-functionally with Clinical Development, Biostatistics, Regulatory, and Program Management in leading the planning and preparation of high-quality clinical regulatory documents.

The senior medical writer will produce protocols, publications, study reports, investigator brochures, narratives, and module documents, to support drug development under brisk timelines.

Qualifications

• Minimum 5 years as a medical writer in CRO/biotech/pharmaceutical field.
• Bachelor’s degree or higher in a relevant field.
• Experience writing protocols, study reports, investigator brochures, module 2 and 5 documents.
• Strong written and verbal communication skills in English.

Responsibilities

• Lead the execution of documents, including project management tasks and timelines.
• Coordinate cross-functional client contributors and internal resources to ensure timely completion.
• Ensure document development adheres to client processes, templates, and guidelines.
• Lead document messaging in collaboration with client and plan kickoff meetings.
• Interpret data and create shell documents to support authoring.
• Facilitate review feedback and plan resolution meetings.
• Ensure consistency across client programs in messaging, formatting, and presentation.
• Conduct literature searches as needed.
• Peer QC review as needed.
• Contribute to medical writing operations and templates as needed.

Skills

Medical writing

Project management

Cross-functional collaboration

English communication

Education

Bachelor's degree or higher in a relevant field

Tools

Microsoft Word

Document management systems

Collaborative authoring tools

Job description

TransPerfect is seeking an organized, motivated senior medical writer to partner cross-functionally with Clinical Development, Biostatistics, Regulatory, and Program Management in leading the planning and preparation of high-quality clinical regulatory documents.

The senior medical writer will produce protocols, publications, study reports, investigator brochures, narratives, and module documents, to support drug development under brisk timelines.