Senior Medical Writer | UK

TransPerfect; United Kingdom; On-site; GBP 65,000 - 90,000; Full time

Job summary

TransPerfect is seeking an organized, motivated senior medical writer to partner across Clinical Development, Biostatistics, Regulatory, and Program Management, leading planning and preparation of high-quality regulatory documents in a fast-paced drug development setting.

You will produce protocols, publications, study reports, investigator brochures, narratives, and module documents per client and agency guidelines, supporting timelines with cross-functional collaboration.

Qualifications

• 5+ years of medical writing experience in the CRO/biotech/pharmaceutical field.
• Bachelor’s degree or higher in a relevant field.
• Experience writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents.
• Oncology, Infectious Disease, or Vaccine experience desired.
• Strong written and verbal communication skills in English.
• Flexibility to work across multiple therapeutic areas and templates.

Responsibilities

• Lead the execution of documents, including project management tasks such as creating, maintaining, and communicating timelines
• Coordinate cross-functional client contributors and internal resources (e.g., QC, publishing) to ensure timely completion of documents
• Ensure document development adheres to client processes, templates, and instructional documents
• Serve as an expert on client document management system and related tools, templates, and procedures
• Lead document message development in collaboration with client
• Interpret data and create shell documents to support authoring
• Plan and lead kickoff meetings
• Facilitate resolution of review feedback including planning and leading comment resolution meetings
• Follow-up with individual team members to resolve outstanding review feedback
• Ensure consistency among client programs in terms of messaging, formatting, and presentation of documents
• Conduct literature searches as needed
• Perform peer QC review as needed
• Contribute to medical writing operational initiatives (e.g., templates, style guides, reference management)
• Experience (5+ years) as a medical writer in the CRO/biotech/pharmaceutical field
• Familiarity with lean authoring approaches and structured content management
• Familiarity with ICH and US (and ex-US) regulatory requirements; MS Word proficiency

Education

Bachelor’s degree or higher in a relevant field

Tools

Microsoft Word

Document management systems

Collaborative authoring tools

Job description

We’re seeking an organized, motivated, and collaborative individual for our medical writing team.

The senior medical writer will partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management in leading the planning and preparation of high-quality clinical regulatory documents. The medical writer may produce protocols, publications, study reports, investigator brochures, narratives, and module documents, according to client and agency guidelines, to support drug development under brisk timelines.

Responsibilities

• Lead the execution of documents, including project management tasks such as creating, maintaining, and communicating timelines
• Coordinate cross-functional client contributors and stakeholders as well as internal resources (e.g., quality control [QC], publishing) to ensure timely completion of documents
• Ensure document development adheres to any relevant client processes, templates, and instructional documents
• Serve as an expert on client document management system and related tools, templates, and procedures to ensure efficient document development
• Lead document message development in collaboration with client
• Interpret data and create shell documents to support authoring
• Plan and lead kickoff meetings
• Facilitate resolution of review feedback including planning and leading comment resolution meetings (curate review comments to ensure meetings are efficient)
• Follow-up with individual team members as needed to resolve outstanding review feedback
• Ensure consistency among client programs in terms of messaging, formatting, and presentation of documents
• Conduct literature searches as needed
• Perform peer QC review as needed
• Contribute to medical writing operational initiatives (e.g., templates, style guides, reference management), if needed
• Experience (5+ years) as a medical writer in the CRO/biotech/pharmaceutical field
• Bachelor’s degree or higher in a relevant field
• Oncology, Infectious Disease, or Vaccine experience desired
• Experience desired in writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents
• Flexibility to work across multiple therapeutic areas, if needed
• Experience writing documents according to established processes and document templates
• Familiarity with lean authoring approaches and structured content management
• Familiarity with the requirements for preparation of key clinical and regulatory documents, including ICH and US regulatory requirements; working knowledge of ex-US regulatory requirements is desired
• Expertise with Microsoft Word and other Microsoft applications
• Experience developing documents using document management systems, collaborative authoring tools, and review tools
• Comfortable adapting to new tools and technologies, if needed
• Ability to work both independently and collaboratively in the face of competing priorities
• Service-oriented and proactive approach to project management
• Excellent conflict management and negotiation skills
• Comfortable providing suggestions based on previous experience
• Strong written and verbal communication skills in English

TransPerfect provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law

For more information on the TransPerfect Family of Companies, please visit our website at www.transperfect.com.