Senior Medical Writer: Lead Regulatory Docs

TransPerfect Translations International; Greater London; Hybride; GBP 65 000 - 95 000; Plein temps

Résumé du poste

TransPerfect Translations International seeks a highly organized, motivated, and collaborative senior medical writer to join our medical writing team in Greater London.

You will partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management in leading the planning and preparation of high-quality clinical regulatory documents for drug development under tight timelines.

Qualifications

• Experience (5+ years) as a medical writer in the CRO/biotech/pharmaceutical field.
• Bachelor’s degree or higher in a relevant field.
• Oncology, Infectious Disease, or Vaccine experience desired.
• Experience writing documents according to established processes and templates.
• Familiarity with lean authoring approaches and structured content management.

Responsabilités

• Lead the execution of documents, including project management tasks such as creating, maintaining, and communicating timelines.
• Coordinate cross-functional client contributors and internal resources (e.g., QC, publishing) 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, templates, and procedures to ensure efficient document development.
• 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 including planning and leading comment resolution meetings.

Connaissances

Medical writing

Project management

Cross-functional collaboration

Regulatory document knowledge

Communication skills

Formation

Bachelor’s degree or higher (relevant field)

Outils

Microsoft Word

Document management systems

Collaborative authoring tools

Review tools

Description du poste

TransPerfect Translations International seeks a highly organized, motivated, and collaborative senior medical writer to join our medical writing team in Greater London.

You will partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management in leading the planning and preparation of high-quality clinical regulatory documents for drug development under tight timelines.