Senior Medical Writer

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

📋 Description

• Lead the implementation of clinical regulatory documents and associated project management activities, including the creation, maintenance, and communication of timelines.

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

• Ensure that document development adheres to client processes, templates, and instructional guidelines.

• Act as an authority on client document management systems, tools, templates, and procedures.

• Drive document message development in collaboration with clients.

• Analyze data and create shell documents to facilitate the authoring process.

• Organize and lead kickoff meetings.

• Manage the review-feedback resolution process, including planning and leading 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 when required.

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

⛳️ Requirements

• Over 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 Vaccine fields is preferred.

• Familiarity with writing clinical study reports, protocols, protocol amendments, investigator brochures, Module 2, and Module 5 documents is desirable.

• Flexibility to work across diverse therapeutic areas.

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

• Knowledge of lean authoring methodologies and structured content management.

• Understanding of the requirements for essential clinical and regulatory documents, including ICH and US regulatory standards.

• Working knowledge of international regulatory requirements is preferred.

• Proficiency with Microsoft Word and other Microsoft applications.

• Experience in developing documents using document management systems, collaborative authoring tools, and review platforms.

• Adaptable to new tools and technologies.

• Ability to work both independently and collaboratively in the face of competing priorities.

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

• Strong conflict management and negotiation abilities.

• Willingness to offer suggestions based on past experiences.

• Excellent written and verbal communication skills in English.

• Must reside in the UK and be legally authorized to work in the UK.

🏝️ 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 law.

• Options for permanent, fixed-term, and freelance/contractor employment arrangements are available.

• Work models include onsite, hybrid, and remote opportunities for London or Manchester.