Senior Medical Writer - Regulatory Documentation Lead

TransPerfect; United Kingdom; Sur place; GBP 65 000 - 90 000; Plein temps

Résumé du poste

TransPerfect is seeking an organized, motivated senior medical writer to partner across Clinical Development, Biostatistics, Regulatory, and Program Management, leading planning and preparation of high-quality regulatory documents in a fast-paced drug development setting.

You will produce protocols, publications, study reports, investigator brochures, narratives, and module documents per client and agency guidelines, supporting timelines with cross-functional collaboration.

Qualifications

• 5+ years of medical writing experience in the CRO/biotech/pharmaceutical field.
• Bachelor’s degree or higher in a relevant field.
• Experience writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents.
• Oncology, Infectious Disease, or Vaccine experience desired.
• Strong written and verbal communication skills in English.
• Flexibility to work across multiple therapeutic areas and templates.

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
• 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
• Follow-up with individual team members to resolve outstanding review feedback
• Ensure consistency among client programs in terms of messaging, formatting, and presentation of documents
• Conduct literature searches as needed
• Perform peer QC review as needed
• Contribute to medical writing operational initiatives (e.g., templates, style guides, reference management)
• Experience (5+ years) as a medical writer in the CRO/biotech/pharmaceutical field
• Familiarity with lean authoring approaches and structured content management
• Familiarity with ICH and US (and ex-US) regulatory requirements; MS Word proficiency

Formation

Bachelor’s degree or higher in a relevant field

Outils

Microsoft Word

Document management systems

Collaborative authoring tools

Description du poste

TransPerfect is seeking an organized, motivated senior medical writer to partner across Clinical Development, Biostatistics, Regulatory, and Program Management, leading planning and preparation of high-quality regulatory documents in a fast-paced drug development setting.

You will produce protocols, publications, study reports, investigator brochures, narratives, and module documents per client and agency guidelines, supporting timelines with cross-functional collaboration.