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 guidelines.

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

• Coordinate contributions from cross-functional client 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 specialist on 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 the authoring process.

• Organize and lead kickoff meetings.

• Manage review feedback and conduct meetings for comment resolution.

• Follow up with team members to address any 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 required.

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

⛳️ Requirements

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

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

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

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

• Flexibility to work across various therapeutic areas, as needed.

• Proven experience in writing documents according to established processes and templates.

• Familiarity with lean authoring methods and structured content management is an advantage.

• Knowledge of key clinical and regulatory document requirements, including ICH and US regulatory standards; familiarity with 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.

• Ability to adapt to new tools and technologies, if necessary.

• Capability to work both independently and collaboratively amidst competing priorities.

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

• Excellent conflict management and negotiation abilities.

• Comfortable providing insights based on prior experience.

• Strong written and verbal communication skills in English.

• Must reside in Poland and be legally authorized to work there (application question).

🏝️ 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.