Senior Medical Writer

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

📋 Description

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

• Create protocols, publications, study reports, investigator brochures, narratives, and module documents.

• Direct document execution and project management activities, which include establishing, updating, and communicating timelines.

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

• Ensure that document creation 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 messages in collaboration with clients.

• Analyze data and prepare shell documents to assist with authoring tasks.

• Organize and facilitate kickoff meetings.

• Manage review feedback and comment resolution meetings.

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

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

• Conduct literature searches as required.

• Perform peer quality control reviews as necessary.

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

⛳️ Requirements

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

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

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

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

• Ability to work flexibly across multiple therapeutic areas.

• Experience in composing documents according to established processes and templates.

• Familiarity with lean authoring techniques 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 developing documents utilizing document management systems, collaborative authoring tools, and review platforms.

• Capability to adapt to new tools and technologies.

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

• A service-oriented and proactive attitude towards project management.

• Skills in conflict management and negotiation.

• Excellent written and verbal communication abilities in English.

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

🏝️ Benefits

• Full-time, permanent employment opportunity.

• Commitment to equal employment opportunities without regard to protected characteristics.