Senior Medical Writer — Lead Regulatory Docs

transperfect; Barcelona; Presencial; EUR 55.000 - 75.000; Jornada completa

Descripción de la vacante

TransPerfect seeks an organized, motivated senior medical writer to lead cross-functional planning and preparation of high-quality regulatory documents in Barcelona. You will collaborate with Clinical Development, Biostatistics, Regulatory, and Program Management to produce protocols, study reports, narratives, and investigator brochures under tight timelines.

The role requires 5+ years in medical writing within CRO/biotech/pharma, a Bachelor’s degree or higher, and experience with

Formación

• 5+ years' experience as a medical writer in CRO/biotech/pharmaceutical
• Bachelor’s degree or higher in a relevant field
• Oncology, Infectious Disease, or Vaccine experience desired
• Experience writing study reports, protocols, investigator brochures, and modules
• Familiarity with ICH and US regulatory requirements; ex-US knowledge is desirable
• Proficiency with Microsoft Word and other MS applications

Responsabilidades

• Lead document execution and manage timelines
• Coordinate cross-functional contributors and internal resources
• Ensure document development adheres to client processes and templates
• Serve as an expert on client document management systems
• Lead document message development in collaboration with clients
• Plan and lead kickoff meetings
• Facilitate resolution of review feedback and plan comment resolution meetings
• Ensure messaging consistency across client programs
• Conduct literature searches as needed
• Perform peer QC reviews as needed
• Contribute to medical writing operational initiatives if needed

Conocimientos

Medical writing

Project management

Communication skills

Regulatory terminology

Educación

Bachelor’s degree or higher in a relevant field

Herramientas

Microsoft Word

Descripción del empleo

TransPerfect seeks an organized, motivated senior medical writer to lead cross-functional planning and preparation of high-quality regulatory documents in Barcelona. You will collaborate with Clinical Development, Biostatistics, Regulatory, and Program Management to produce protocols, study reports, narratives, and investigator brochures under tight timelines.

The role requires 5+ years in medical writing within CRO/biotech/pharma, a Bachelor’s degree or higher, and experience with