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Principal Medical Writer (M/W/D)
Responsible for planning and preparing high quality medical writing deliverables and disclosure/transparency activities (e.g., study protocols, clinical study reports, statistical analysis plans, Investigator Brochures, relevant modules of regulatory dossiers, Plain Language Summaries, Results Summaries for disclosure, briefing books).
Participates in the development of Best Practices, SOPs work instructions, style guides and content guides to ensure efficient preparation of high quality medical writing deliverables
Provides input into the strategy for medical writing vendor selection, defines the scope of work to be outsourced and is responsible for medical writing vendor management.
Responsible for continuous improvement of in-house medical writing
A solid understanding of the Clinical Development Process, including the documents that are required at each stage of development
An excellent understanding of all aspects of ICH GCP, SOPs, and international publication planning guidelines
Successful track record of leading complex clinical / regulatory writing projects
Able to work independently on CSRs and module 2 clinical documents
Prior experience of working in the role of medical writer within the CRO/Pharma/Biotech industry
As a guide, a minimum of 7 years Clinical experience in the role of medical writer
Excellent level of English language proficiency
Expert MS Office skills with a special focus on word processing , tables and graphics, spreadsheet presentations and template
Start: asap
Duration: 12 months
Capacity: 4-5 days per week
Location: Hybrid 50% ideally, can be remote
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