Senior Medical Writer

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

📋 Description

• Oversee the planning and creation 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, including the creation, maintenance, and communication of timelines.

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

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

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

• Drive document message development in collaboration with clients.

• Analyze data and develop shell documents to assist in authoring.

• Organize and lead kickoff meetings.

• Facilitate the resolution of review feedback and manage comment-resolution meetings.

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

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

• Conduct literature searches as 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 sectors.

• 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, and module 2 and module 5 documents is desired.

• Willingness to work across multiple therapeutic areas if required.

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

• Familiarity with lean authoring methods and structured content management.

• Understanding of the requirements for key clinical and regulatory documents, including ICH and US regulatory standards.

• 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 tools.

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

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

• Service-oriented and proactive approach to managing projects.

• Strong conflict management and negotiation abilities.

• Comfortable providing insights based on prior experience.

• Exceptional written and verbal communication skills in English.

• Candidates must reside in Spain and be legally authorized to work in Spain.

🏝️ 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.