Specialty
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The role
The company is hiring a Senior Medical Writer for its medical writing team. The writer leads planning and preparation of clinical regulatory documents with client teams in clinical development, operations, biostatistics and regulatory. Fully remote in the US, with on-site attendance at key client meetings when requested.
What you will do
- Lead the execution of clinical regulatory documents, including timelines and project tasks
- Coordinate client contributors and internal teams such as QC and publishing to finish documents on time
- Develop document messaging with the client and create shell documents from data
- Plan and lead kickoff meetings and comment-resolution meetings on review feedback
- Keep messaging, formatting and presentation consistent across client programs
- Run literature searches and peer QC reviews as needed
What they ask for
- 5+ years as a medical writer in the CRO, biotech or pharmaceutical field
- Bachelor's degree or higher in a relevant field
- Experience with clinical study reports, protocols, investigator brochures and module 2 and 5 documents
- Knowledge of ICH and US regulatory requirements; oncology, infectious disease or vaccine experience desired
- Strong written and verbal communication skills
- Skilled in Microsoft Word and document management and review tools
- Able to attend key client meetings on site when requested
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