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.

• Direct document execution, including project management responsibilities and timeline communication.

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

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

• Act as an expert 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.

• Organize and lead kickoff meetings.

• Facilitate meetings for review feedback and resolution of comments.

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

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

• Conduct literature searches.

• Carry out peer quality-control reviews.

• Contribute to medical writing operational initiatives such as templates, style guides, and reference management.

• Collaborate cross-functionally with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management teams.

⛳️ Requirements

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

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

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

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

• Flexibility to work across various therapeutic areas.

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

• Familiarity with lean authoring methods and structured content management.

• Knowledge of ICH and US regulatory requirements; familiarity with ex-US regulatory requirements is a plus.

• Proficiency in Microsoft Word and other Microsoft applications.

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

• Ability to adapt to new tools and technologies comfortably.

• Capacity to work independently and collaboratively while managing competing priorities.

• Service-oriented and proactive approach to project management.

• Excellent conflict management and negotiation abilities.

• Strong written and verbal communication skills in English.

• Must be based in Spain and legally authorized to work in Spain.

🏝️ Benefits

• Full-time, permanent employment.

• Equal employment opportunity without regard to protected characteristics.