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Principal Clinical Medical Writer
Company Name
BioMarin Pharmaceutical Inc.
Job Description
The Principal Clinical Medical Writer at BioMarin Pharmaceutical Inc. oversees medical writing staff and manages documentation requirements for clinical development programs.
Responsibilities
- Authoring/editing protocols
- Clinical study reports
- Safety reports
- Regulatory filings
- Managing study team participation
- Timelines and review processes
- Representing Medical Writing in cross-functional meetings
Requirements
- Master's degree (preferred)
- At least 8 years of pharmaceutical industry experience as a medical writer
- Strong leadership, planning, and delegation skills
- Comprehensive understanding of drug development and regulatory documentation