Senior Medical Writer

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

📋 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 client stakeholders and internal resources like quality control and publishing.

• Ensure that document development adheres to client processes, templates, and 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 draft documents for authoring purposes.

• Organize and lead kickoff meetings.

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

• Follow up with team members to address unresolved feedback.

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

• Conduct literature searches as necessary.

• Perform peer quality control reviews as required.

• 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, or pharmaceutical sectors.

• Bachelor’s degree or higher in a related field.

• Experience in Oncology, Infectious Disease, or Vaccines is preferred.

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

• Ability to adapt to multiple therapeutic areas.

• Experience in crafting documents according to established procedures and document templates.

• Knowledge of lean authoring techniques and structured content management.

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

• Proficient in Microsoft Word and other Microsoft applications.

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

• Capability to adapt to new tools and technologies.

• Ability to work independently and collaboratively in a fast-paced environment with competing priorities.

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

• Excellent skills in conflict management and negotiation.

• Strong written and verbal communication abilities in English.

• Must be based in France and legally authorized to work there.

🏝️ 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.