Senior Medical Writer

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

📋 Description

• Collaborate across various teams including Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management.

• 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 and project management activities, which include creating, maintaining, and communicating timelines.

• Coordinate contributions from clients, 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 protocols.

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

• Analyze data and create preliminary document structures.

• Organize and lead kickoff meetings.

• Facilitate review feedback and manage comment resolution meetings.

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

• Ensure uniformity in messaging, formatting, and presentation across client programs.

• Conduct literature searches as necessary.

• Perform peer quality control reviews as needed.

• Contribute to 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 sector.

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

• Experience in Oncology, Infectious Disease, or Vaccine development is preferred.

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

• Ability to work flexibly across various therapeutic areas.

• Experience in authoring documents in accordance with established processes and templates.

• Familiarity with lean authoring methodologies and structured content management.

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

• Proficient in Microsoft Word and other Microsoft applications.

• Experience in creating documents using document management systems, collaborative authoring tools, and review tools.

• Comfortable with adapting to new tools and technologies.

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

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

• Excellent conflict management and negotiation abilities.

• Strong written and verbal communication skills in English.

• Candidates must reside in Spain and hold legal authorization 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 state, federal, or local law.