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 

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.
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