Senior Medical Writer: Lead Regulatory Documents

TransPerfect; France; Sur place; EUR 70 000 - 100 000; Plein temps

Résumé du poste

TransPerfect seeks a senior medical writer to join its clinical development team. The role partners with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management to plan and prepare high-quality regulatory documents under tight timelines.

You will lead document planning, cross-functional coordination, and adherence to client templates and processes while developing protocols, study reports, narratives, and Investigator Brochures.

Qualifications

• Bachelor’s degree or higher in a relevant field.
• 5+ years of medical writing experience in CRO/biotech/pharma.
• Experience writing clinical study reports, protocols, and investigator brochures.

Responsabilités

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

Connaissances

Medical writing

Cross-functional collaboration

Project management

English writing

Formation

Bachelor's degree or higher in a relevant field

Outils

Microsoft Word

Document management systems

Collaboration tools

Description du poste

TransPerfect seeks a senior medical writer to join its clinical development team. The role partners with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management to plan and prepare high-quality regulatory documents under tight timelines.

You will lead document planning, cross-functional coordination, and adherence to client templates and processes while developing protocols, study reports, narratives, and Investigator Brochures.