Senior Medical Writer

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

📋 Description

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

• Generate protocols, publications, study reports, investigator brochures, narratives, and module documents in alignment with client and agency standards.

• Manage document execution and project tasks, which includes establishing, updating, and communicating timelines.

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

• Ensure that document development adheres to client protocols, templates, and instructional materials.

• Act as a specialist in client document management systems, tools, templates, and procedures.

• Guide document messaging development in collaboration with clients.

• Analyze data and create initial document frameworks to assist in authoring.

• Organize and lead kickoff meetings.

• Facilitate the resolution of review feedback, including conducting comment resolution meetings.

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

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

• Conduct literature searches when necessary.

• Perform peer quality-control reviews as required.

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

⛳️ Requirements

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

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

• 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 is desired.

• Willingness to work across various therapeutic areas, if necessary.

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

• Familiarity with lean authoring methods and structured content management.

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

• Proficiency in Microsoft Word and other Microsoft applications.

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

• Ability to adapt to new tools and technologies as needed.

• Capable of working independently and collaboratively while managing competing priorities.

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

• Strong conflict management and negotiation abilities.

• Comfortable offering suggestions based on prior experience.

• Exceptional written and verbal communication skills in English.

• Residing in France and legally authorized to work there.

🏝️ Benefits

• Equal employment opportunity without discrimination based on race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by applicable laws.

• Options for employment include permanent, fixed-term, and freelance/contractor arrangements.