Related skills
documentation excel microsoft office regulatory compliance ectd📋 Description
- Plan, write, edit, format, and QC clinical documents
- Develop protocols, IBs, CSR narratives per guidelines
- Ensure documents follow Precision MW Style Guide and SOPs
- Manage documents from template to final versions with teams
- Extract key study messages from data for clear communication
- Support literature-based research to back writing activities
🎯 Requirements
- BS degree or equivalent in a scientific/medical field
- 5+ years as a medical writer in sponsor/CRO setting
- MS Office, Teams, Acrobat proficiency
- Knowledge of ICH, FDA, GCP and eCTD
- Impeccable attention to detail; timely writing
- Advanced degree (MS/PhD) preferred
🎁 Benefits
- discretionary annual bonus
- health insurance
- retirement savings benefits
- life insurance and disability benefits
- parantal leave
- paid time off for sick leave and vacation
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