Senior Medical Writer

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

📋 Description

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

• Collaborate across various teams, including Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management clients.

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

• Direct document execution and project management activities, which include establishing, updating, and communicating timelines.

• Organize contributions from clients, stakeholders, and internal resources such as quality control and publishing teams.

• Ensure that document creation adheres to client protocols, templates, and guidelines.

• Act as a subject matter expert 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 as needed.

• Organize and lead kickoff meetings.

• Manage the resolution of feedback during reviews and lead discussions to address comments.

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

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

• Conduct literature searches as required.

• Carry out peer quality control reviews as necessary.

• Participate in medical writing operational initiatives such as developing templates, style guides, and reference management.

⛳️ Requirements

• Minimum of 5 years of experience as a medical writer within the CRO, biotech, or pharmaceutical sectors.

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

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

• Ability to work flexibly across various therapeutic areas.

• Experience in producing documents in accordance with established processes and templates.

• Knowledge of lean authoring techniques and structured content management.

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

• Proficient in Microsoft Word and other Microsoft applications.

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

• Capability to adapt to new tools and technologies.

• Proficient in working both independently and collaboratively while managing competing priorities.

• Service-oriented mindset with a proactive approach to project management.

• Strong conflict resolution and negotiation capabilities.

• Excellent written and verbal communication skills in English.

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

🏝️ Benefits

• Full-time, permanent employment position.

• Equal employment opportunities available regardless of protected characteristics.