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.

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

• Manage document execution and project management tasks, including the creation, maintenance, and communication of timelines.

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

• Ensure the development of documents adheres to client processes, templates, and instructional guidelines.

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

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

• Analyze data and generate shell documents to aid in authorship.

• Organize and direct kickoff meetings.

• Facilitate the resolution of review feedback and lead meetings to address comments.

• Follow up with team members to address any unresolved review feedback.

• Ensure uniformity in messaging, formatting, and presentation across client programs.

• Conduct literature searches as required.

• Perform peer quality control reviews as necessary.

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

⛳️ Requirements

• A minimum of 5 years of experience as a medical writer in the CRO/biotech/pharmaceutical sectors.

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

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

• Proven experience in writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents.

• Ability to work flexibly across various therapeutic areas.

• Experience in writing documents following established processes and templates.

• Knowledge of lean authoring methods and structured content management is advantageous.

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

• Proficiency in Microsoft Word and other Microsoft applications.

• Experience with document management systems, collaborative authoring tools, and review platforms.

• Ability to adapt to new tools and technologies.

• Capable of working both independently and collaboratively in a fast-paced environment with competing priorities.

• A service-oriented and proactive approach to project management.

• Strong conflict management and negotiation skills.

• Excellent written and verbal communication skills in English.

• Must reside in the Netherlands and have legal authorization to work there.

🏝️ Benefits

• Full-time, permanent employment.

• Equal employment opportunity regardless of protected characteristics.