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.

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

• Generate protocols, publications, study reports, investigator brochures, narratives, and module documents.

• Direct document execution and project management activities, including the creation, maintenance, and communication of 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 guidelines.

• Act as a subject matter expert on client document management systems, tools, templates, and procedures.

• Lead the development of document messaging with clients.

• Analyze data and create shell documents.

• Organize and lead kickoff meetings.

• Facilitate the resolution of review feedback and lead meetings for comment resolution.

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

• 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 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 industry.

• A bachelor’s degree or higher in a relevant discipline.

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

• Familiarity with writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents is desired.

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

• Proven experience in drafting documents in accordance with established processes and templates.

• Understanding of lean authoring approaches and structured content management.

• Knowledge of requirements for key clinical and regulatory documents, including ICH and US regulatory standards; 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 platforms.

• Adaptability to new tools and technologies, as required.

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

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

• Excellent conflict resolution and negotiation abilities.

• Strong written and verbal communication skills in English.

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

🏝️ Benefits

• Equal employment opportunity for all individuals regardless of race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.