Senior Medical Writer

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

📋 Description

• Oversee the execution of clinical regulatory documents along with associated project management responsibilities, which include developing, updating, and sharing timelines.

• Coordinate contributions from cross-functional client teams, stakeholders, and internal resources such as quality control and publishing departments.

• 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 in collaboration with clients.

• Analyze data and generate shell documents to assist in the authoring process.

• Organize and lead kickoff meetings.

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

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

• Maintain consistency in messaging, formatting, and presentation across various 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/pharmaceutical sectors.

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

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

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

• Willingness to work across various therapeutic areas.

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

• Familiarity with lean authoring methodologies and structured content management.

• Understanding of the requirements for key clinical and regulatory documents, including ICH and US regulatory guidelines; knowledge of ex-US regulatory standards is preferred.

• Proficient in Microsoft Word and other Microsoft applications.

• Experience with document management systems, collaborative authoring tools, and review tools.

• Comfortable with adapting to new tools and technologies.

• Ability to work both independently and collaboratively in a fast-paced environment with competing priorities.

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

• Strong conflict management and negotiation skills.

• Comfortable providing insights based on previous experiences.

• Excellent 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.