Senior Medical Writer

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

📋 Description

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

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

• Lead the execution of documents by creating, maintaining, and communicating timelines.

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

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

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

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

• Analyze data and create shell documents to facilitate the writing process.

• Organize and lead kickoff meetings.

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

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

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

• Conduct literature searches as necessary.

• Execute peer quality control reviews as required.

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

⛳️ Requirements

• A minimum of 5 years of experience as a medical writer in the CRO, biotech, or pharmaceutical industry.

• 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 preferred.

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

• Proficient in writing documents following established processes and document templates.

• Knowledge of lean authoring methodologies and structured content management.

• Familiarity with the requirements for essential clinical and regulatory documents, including ICH and US regulatory standards; knowledge of ex-US regulatory requirements is a plus.

• Proficient 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 required.

• Capability to work both independently and collaboratively in a fast-paced environment.

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

• Strong conflict management and negotiation skills.

• Comfortable providing recommendations based on prior experience.

• Excellent written and verbal communication skills in English.

• Residing in France and legally authorized to work there.

🏝️ Benefits

• Equal employment opportunity without regard to race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by law.