Specialty
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The role
The company is hiring a senior medical writer to lead clinical regulatory documents for pharma and biotech client teams. This is a remote role for applicants in Brazil.
What you will do
- Plan and lead preparation of clinical regulatory documents
- Coordinate client contributors and internal QC and publishing
- Run kickoff and comment resolution meetings
- Conduct literature searches and peer QC reviews
What they ask for
- 5+ years as a medical writer in CRO, biotech or pharma
- Bachelor's degree or higher in a relevant field
- Experience writing CSRs, protocols, investigator brochures and module 2/5 documents
- Knowledge of ICH and US regulatory requirements
- Experience with document management and collaborative authoring tools
- Strong written and spoken English
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