Senior Medical Writer | UK

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
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
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
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
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
Lead document message development in collaboration with client
* Interpret data and create shell documents to support authoring
Interpret data and create shell documents to support authoring
* Plan and lead kickoff meetings
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)
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
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
Ensure consistency among client programs in terms of messaging, formatting, and presentation of documents
* Conduct literature searches as needed
Conduct literature searches as needed
* Perform peer QC review as needed
Perform peer QC review as needed
* Contribute to medical writing operational initiatives (e.g., templates, style guides, reference management), if 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
Experience (5+ years) as a medical writer in the CRO/biotech/pharmaceutical field
* Bachelor’s degree or higher in a relevant field
Bachelor’s degree or higher in a relevant field
* Oncology, Infectious Disease, or Vaccine experience desired
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
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
Flexibility to work across multiple therapeutic areas, if needed
* Experience writing documents according to established processes and document templates
Experience writing documents according to established processes and document templates
* Familiarity with lean authoring approaches and structured content management
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
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
Expertise with Microsoft Word and other Microsoft applications
* Experience developing documents using document management systems, collaborative authoring tools, and review tools
Experience developing documents using document management systems, collaborative