Senior Medical Writer

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

📋 Description

• Oversee 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 standards.

• Direct document execution, which includes establishing, maintaining, and communicating timelines.

• Coordinate contributions from cross-functional client participants, 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 regarding the client document management system, tools, templates, and procedures.

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

• Analyze data and create shell documents to facilitate authoring.

• Organize and lead kickoff meetings.

• Manage the resolution of review feedback and conduct comment resolution meetings.

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

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

• Conduct literature searches as required.

• Perform peer quality-control reviews as necessary.

• Contribute to operational initiatives in medical writing, including templates, style guides, and reference management.

⛳️ Requirements

• A 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 Vaccines is preferred.

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

• Willingness to work across various therapeutic areas, if necessary.

• Experience in authoring documents following established processes and document templates.

• Familiarity with lean authoring methodologies and structured content management.

• Knowledge of ICH and US regulatory requirements; familiarity with 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.

• Adaptability to new tools and technologies when required.

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

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

• Strong skills in conflict management and negotiation.

• Comfortable making suggestions based on prior experience.

• Excellent written and verbal communication skills in English.

• Must reside in Poland and have legal authorization to work there, as indicated in the application questions.

🏝️ 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.