Senior Medical Writer

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

📋 Description

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

• Take the lead in the planning and preparation of high-quality clinical regulatory documents.

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

• Oversee document execution, which includes creating, maintaining, and communicating 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 documents.

• Act as an authority on client document management systems, tools, templates, and procedures.

• Direct document message development in partnership with clients.

• Analyze data and create shell documents to facilitate authoring.

• Organize and lead kickoff meetings.

• Manage review feedback resolution, including planning and leading comment resolution meetings.

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

• Maintain consistency 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 such as templates, style guides, and reference management.

⛳️ Requirements

• Minimum of 5 years of experience as a medical writer in the CRO/biotech/pharmaceutical sector.

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

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

• Desired experience in authoring clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents.

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

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

• Familiarity with lean authoring techniques and structured content management.

• Understanding of the requirements for key clinical and regulatory document preparation, including ICH and US regulatory requirements; knowledge of ex-US regulatory requirements is a plus.

• Proficiency 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 when necessary.

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

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

• Strong conflict management and negotiation skills.

• Willingness to provide recommendations based on past experiences.

• Excellent written and verbal communication skills in English.

• Residing in Portugal and 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.

• Option for permanent employment arrangement available.

• Fixed-term employment arrangement options available.

• Freelance/Contractor employment arrangement available.

• Remote work model is an available option.

• Onsite or hybrid work model in Lisbon or Porto is also available.