Senior Medical Writer

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

📋 Description

• Oversee the development of clinical regulatory documents and associated project management activities.

• Establish, update, and communicate project timelines effectively.

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

• Ensure all documents adhere to client procedures, templates, and guidelines.

• Act as an authority on client document management systems, tools, formats, and protocols.

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

• Analyze data and generate initial document drafts for authorship.

• Organize and lead kickoff meetings efficiently.

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

• Follow up with colleagues to address any outstanding review comments.

• Maintain consistency in messaging, formatting, and presentation of documents across client initiatives.

• Conduct literature searches as required.

• Perform peer quality control reviews when necessary.

• Participate in medical writing operational projects such as template creation, style guides, and reference management.

⛳️ Requirements

• Minimum of 5 years of experience as a medical writer in the CRO, biotech, or pharmaceutical industry.

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

• Experience in oncology, infectious diseases, or vaccines is preferred.

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

• Adaptability to work across various therapeutic areas.

• Experience in producing documents in accordance with defined processes and templates.

• Knowledge of lean authoring methods and structured content management.

• Familiarity with ICH and US regulatory standards; knowledge of non-US regulatory guidelines is advantageous.

• Proficiency in Microsoft Word and other Microsoft software applications.

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

• Capability to adapt to new technologies and tools.

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

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

• Skills in conflict resolution and negotiation.

• Excellent written and verbal communication skills in English.

• Resident in the UK and legally authorized to work in the UK.

🏝️ Benefits

• Full-time, permanent position.

• Option for remote work.

• Commitment to equal employment opportunities.