Senior Medical Writer

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

📋 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 creating, maintaining, and communicating timelines.

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

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

• 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 create shell documents to support the writing process.

• Organize and lead kickoff meetings.

• Facilitate the resolution of review feedback and conduct comment resolution meetings.

• Follow up with team members to address any outstanding review 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 operational initiatives in medical writing, including templates, style guides, and reference management.

⛳️ Requirements

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

• 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 is desirable.

• Flexibility to work across various therapeutic areas.

• Experience in producing documents according to established processes and templates.

• Knowledge of lean authoring techniques and structured content management.

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

• Proficiency in Microsoft Word and other Microsoft applications.

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

• Excellent written and verbal communication skills in English.

• Ability to work both independently and collaboratively while managing competing priorities.

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

• Strong conflict management and negotiation skills.

• Capacity to adapt to new tools and technologies.

🏝️ 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.