Senior Medical Writer

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

📋 Description

• Oversee the implementation of clinical regulatory documents, including managing projects such as the creation, maintenance, and communication of timelines.

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

• Ensure that document development complies with client processes, templates, and instructional guidelines.

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

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

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

• Organize and lead kickoff meetings.

• Manage the resolution of review feedback, including planning and conducting comment resolution meetings.

• Streamline review comments to make meetings more productive.

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

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

• Conduct literature searches as required.

• Perform peer quality control reviews as needed.

• Participate in 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 in the CRO, biotech, or pharmaceutical industry.

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

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

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

• Willingness to work across multiple therapeutic areas as needed.

• Proven experience in writing documents following established processes and templates.

• Knowledge of lean authoring methodologies and structured content management.

• Understanding of the requirements for key clinical and regulatory document preparation, including ICH and US regulations; familiarity with ex-US regulatory requirements is a plus.

• Proficiency in Microsoft Word and other Microsoft applications.

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

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

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

• A service-oriented and proactive approach to managing projects.

• Strong conflict management and negotiation abilities.

• Confident in providing suggestions based on prior experience.

• Excellent 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 state, federal, or local law.