Senior Medical Writer

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

📋 Description

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

• Collaborate across various functions including Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management client teams.

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

• Manage document execution and project management activities, which include creating, updating, and communicating timelines.

• Coordinate contributions from clients, stakeholders, and internal resources such as quality control and publishing teams.

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

• Act as a subject matter expert on client document management systems, tools, templates, and procedures.

• Drive the development of document messaging with clients.

• Analyze data and create shell documents to aid in authoring.

• Organize and lead kickoff meetings.

• Facilitate meetings for review feedback and resolution of comments.

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

• Maintain consistency across client programs in terms of messaging, formatting, and presentation.

• Conduct literature searches as required.

• Perform peer quality-control reviews as necessary.

• 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 within the CRO/biotech/pharmaceutical industry.

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

• Desired experience in Oncology, Infectious Disease, or Vaccine writing.

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

• Flexibility to work across various therapeutic areas when necessary.

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

• Familiarity with lean authoring practices and structured content management.

• Knowledge of requirements for key clinical and regulatory documents, including ICH and US regulatory requirements; experience with ex-US regulatory requirements is a plus.

• Proficient in Microsoft Word and other Microsoft applications.

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

• Comfortable with adapting to new tools and technologies as needed.

• Ability to work both independently and as part of a team while managing competing priorities.

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

• Strong conflict management and negotiation abilities.

• Willingness to provide suggestions based on prior experience.

• Excellent written and verbal communication skills in English.

• 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 state, federal, or local law.