Senior Medical Writer: Regulatory Docs Lead

TransPerfect; Netherlands; On-site; EUR 70,000 - 100,000; Full time

Job summary

TransPerfect seeks an organized senior medical writer to lead regulatory document planning and cross-functional collaboration within clinical development, biostatistics, regulatory, and operations. You will produce study reports, protocols, investigator brochures, and module documents in line with client and agency guidelines while meeting tight timelines.

You will coordinate internal resources and client contributors, ensure adherence to templates, and drive messages across documents.

Qualifications

• 5+ years of medical writing experience in CRO/biotech/pharma
• Oncology, Infectious Disease, or Vaccine experience desired
• Experience writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2 and 5 documents
• Familiarity with ICH and US regulatory requirements; some ex-US knowledge
• Lean authoring approaches and structured content management

Responsibilities

• Lead the preparation and planning of high-quality clinical regulatory documents
• Coordinate cross-functional client contributors and internal resources to ensure timely completion
• Ensure documents follow client processes, templates, and guidelines
• Serve as an expert on client document management systems and tools
• Lead document message development in collaboration with the client
• Interpret data and create shell documents to support authoring
• Plan and lead kickoff meetings
• Facilitate review feedback and plan resolution meetings
• Follow-up with team members to resolve outstanding feedback
• Ensure consistency across programs for messaging, formatting, and presentation
• Conduct literature searches as needed
• Perform peer QC review as needed
• Contribute to medical writing operational initiatives (templates, style guides)
• Experience (5+) in medical writing in CRO/biotech/pharma
• Bachelor’s degree or higher in a relevant field
• Comfort with multiple therapeutic areas and templates
• Experience in European and US regulatory environments
• Expertise with Microsoft Word and related applications
• Experience with document management & collaboration tools
• Ability to work independently and collaboratively under competing priorities
• Service-oriented and proactive project management approach
• Strong written and verbal English communication skills

Skills

Cross-functional collaboration

Regulatory writing

Project management

Quality control

Clinical documentation

English writing

Microsoft Word

Education

Bachelor’s degree in a relevant field

Tools

Microsoft Word

Job description

TransPerfect seeks an organized senior medical writer to lead regulatory document planning and cross-functional collaboration within clinical development, biostatistics, regulatory, and operations. You will produce study reports, protocols, investigator brochures, and module documents in line with client and agency guidelines while meeting tight timelines.

You will coordinate internal resources and client contributors, ensure adherence to templates, and drive messages across documents.