Senior Medical Writer | Netherlands

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

We’re seeking an organized, motivated, and collaborative individual for our medical writing team.

The senior medical writer 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. The medical writer may produce protocols, publications, study reports, investigator brochures, narratives, and module documents, according to client and agency guidelines, to support drug development under brisk timelines.

Responsibilities

• Lead the execution of documents, including project management tasks such as creating, maintaining, and communicating timelines
• Coordinate cross-functional client contributors and stakeholders as well as internal resources (e.g., quality control [QC], publishing) to ensure timely completion of documents
• Ensure document development adheres to any relevant 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 (curate review comments to ensure meetings are efficient)
• Follow-up with individual team members as needed 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), if needed
• 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 desired in writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents
• Flexibility to work across multiple therapeutic areas, if needed
• Experience writing documents according to established processes and document templates
• Familiarity with lean authoring approaches and structured content management
• Familiarity with the requirements for preparation of key clinical and regulatory documents, including ICH and US regulatory requirements; working knowledge of ex-US regulatory requirements is desired
• Expertise with Microsoft Word and other Microsoft applications
• Experience developing documents using document management systems, collaborative authoring tools, and review tools
• Comfortable adapting to new tools and technologies, if needed
• Ability to work both independently and collaboratively in the face of competing priorities
• Service-oriented and proactive approach to project management
• Excellent conflict management and negotiation skills
• Comfortable providing suggestions based on previous experience
• Strong written and verbal communication skills in English

TransPerfect provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law

For more information on the TransPerfect Family of Companies, please visit our website at www.transperfect.com.