Senior Medical Writer - Regulatory Documents Lead

TransPerfect; España; On-site; EUR 75,000 - 110,000; Full time

Job summary

TransPerfect seeks an organized, motivated senior medical writer to join our medical writing team in Spain. You will partner with Clinical Development, Biostatistics, Regulatory, and Program Management to plan and prepare high-quality regulatory documents, including protocols, study reports, and investigator brochures.

You will lead document execution, coordinate cross-functional contributors, ensure adherence to templates and processes, and support templates, reference management, and lean

Qualifications

• 5+ years as a medical writer in 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
• Strong written and verbal communication in English
• Familiarity with ICH and US regulatory requirements; ex-US regulatory knowledge desired
• Experience with document management systems and review tools

Responsibilities

• Lead the execution of documents, including project management tasks such as creating, maintaining, and communicating timelines
• Coordinate cross-functional client contributors and internal resources to ensure timely completion of documents
• Ensure document development adheres to client processes, templates, and instructions
• Serve as an expert on client document management systems and related tools
• 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 comment resolution meetings
• Follow-up with team members to resolve outstanding feedback
• Ensure consistency among programs in messaging, formatting, and presentation of documents
• Conduct literature searches as needed
• Perform peer QC review as needed
• Contribute to medical writing operational initiatives like templates and style guides
• Familiarity with lean authoring approaches and structured content management
• Experience writing documents according to established processes and templates

Skills

Written and verbal communication

Cross-functional collaboration

Project management

Organizational skills

English proficiency

Education

Bachelor’s degree or higher in a relevant field

Tools

Microsoft Word

Document management systems

Collaborative authoring tools

Job description

TransPerfect seeks an organized, motivated senior medical writer to join our medical writing team in Spain. You will partner with Clinical Development, Biostatistics, Regulatory, and Program Management to plan and prepare high-quality regulatory documents, including protocols, study reports, and investigator brochures.

You will lead document execution, coordinate cross-functional contributors, ensure adherence to templates and processes, and support templates, reference management, and lean