Senior Medical Writer

This is a fully remote position, open to applicants in Netherlands.

📋 Description

• Oversee the planning and preparation of high-quality clinical regulatory documents.

• Generate protocols, publications, study reports, investigator brochures, narratives, and module documents.

• Manage document execution, which includes establishing, maintaining, and communicating timelines.

• Coordinate contributions from cross-functional clients, stakeholders, and internal resources such as quality control and publishing.

• Ensure that document development adheres to client processes, templates, and instructional guidelines.

• Act as an authority on client document management systems, tools, templates, and procedures.

• Guide the development of document messaging in collaboration with clients.

• Analyze data and create shell documents to facilitate authoring.

• Organize and lead kickoff meetings.

• Facilitate the resolution of review feedback and lead meetings focused on comment resolution.

• Follow up with team members to address outstanding review feedback.

• Maintain consistency in messaging, formatting, and presentation across client programs.

• Conduct literature searches as necessary.

• Perform peer quality-control reviews as needed.

• Contribute to medical writing operational initiatives, including templates, style guides, and reference management.

⛳️ Requirements

• Minimum of 5 years of experience as a medical writer in the CRO/biotech/pharmaceutical sector.

• Bachelor’s degree or higher in a relevant discipline.

• Experience in Oncology, Infectious Disease, or Vaccine development is preferred.

• Proven track record of writing clinical study reports, protocols, protocol amendments, investigator brochures, and module 2 and module 5 documents is desirable.

• Flexibility to work across various therapeutic areas.

• Proficient in writing documents in accordance with established processes and document templates.

• Familiar with lean authoring methods and structured content management.

• Understanding of ICH and US regulatory requirements; knowledge of ex-US regulatory requirements is a plus.

• Proficient in Microsoft Word and other Microsoft applications.

• Experience in developing documents using document management systems, collaborative authoring tools, and review tools.

• Comfortable with adapting to new tools and technologies.

• Ability to work both independently and collaboratively while managing competing priorities.

• Service-oriented and proactive approach to project management.

• Strong conflict management and negotiation skills.

• Open to providing suggestions based on past experiences.

• Excellent written and verbal communication skills in English.

• Must be based in the Netherlands and legally authorized to work in the Netherlands.

🏝️ Benefits

• Equal employment opportunity regardless of race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by law.