Senior Medical Writer

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

📋 Description

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

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

• Manage document execution, 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 guidelines.

• Act as an authority on the client document management system and associated tools, templates, and procedures.

• Direct the development of document messages in collaboration with clients.

• Analyze data and create shell documents to assist with authoring.

• Organize and lead kickoff meetings.

• Facilitate the resolution of review feedback and lead meetings to address comments.

• Follow up with team members to clear any unresolved review feedback.

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

• Conduct literature searches as required.

• Perform peer quality control reviews as necessary.

• Contribute to operational initiatives in medical writing such as developing templates, style guides, and managing references.

⛳️ Requirements

• A minimum of 5 years' 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 development is preferred.

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

• Flexibility to work across various therapeutic areas.

• Proficient in writing documents that comply with 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 standards is a plus.

• Proficient in Microsoft Word and other Microsoft Office applications.

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

• Ability to adapt to new tools and technologies effectively.

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

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

• Excellent skills in conflict management and negotiation.

• Strong written and verbal communication skills in English.

• Must be based in the UK and 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.