Senior Medical Writer

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

📋 Description

• Oversee the planning and preparation of high-quality clinical regulatory documents.

• Collaborate across various functions with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management client teams.

• Create protocols, publications, study reports, investigator brochures, narratives, and module documents in compliance with client and agency guidelines.

• Manage 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 materials.

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

• Guide document messaging development with clients.

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

• Organize and lead kickoff meetings.

• Facilitate review feedback and conduct comment resolution meetings.

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

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

• Conduct literature searches as necessary.

• Perform peer quality-control reviews as needed.

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

⛳️ Requirements

• 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 field.

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

• Proven experience 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 required.

• Experience in producing documents in alignment with established processes and templates.

• Familiarity with lean authoring methods and structured content management.

• Knowledge of requirements for key clinical and regulatory documents, including ICH and US regulatory standards; understanding of ex-US regulatory requirements is advantageous.

• Proficient in Microsoft Word and other Microsoft applications.

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

• Comfortable with adapting to new tools and technologies as necessary.

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

• Service-oriented and proactive project management approach.

• Excellent conflict management and negotiation skills.

• Willingness to provide suggestions based on previous experiences.

• Strong written and verbal communication skills in English.

• Must reside in Portugal and be legally authorized to work there.

🏝️ 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 state, federal, or local law.