Principal Medical Writier
$84,400–$211,100 year
On-siteDurham, North Carolina, United States
Job Summary
Lead the development of high-quality clinical and regulatory documents, including Investigator's Brochures, Clinical Study Reports, and Module II summaries, ensuring scientific accuracy and alignment with global regulatory guidelines. Serve as the lead writer for key summary documents, overseeing medical writing activities across multiple compounds while providing strategic guidance to cross-functional teams on document content and regulatory positioning. Manage project planning, timelines, and resource coordination to meet submission deadlines, and mentor other writers to ensure consistent, scientifically sound deliverables. Review and edit documents for accuracy and compliance, contribute to process improvement initiatives, and develop standard operating procedures. Stay current with evolving regulatory requirements and therapeutic area knowledge to drive innovation in document preparation.
Required Qualifications
- Bachelor's degree in a scientific, clinical, regulatory, or related field
- Minimum of 7+ years of experience in medical writing within the biopharmaceutical, biotechnology, or CRO industry
- Strong knowledge of global regulatory requirements and guidelines (e.g., ICH, FDA, EMA) across all phases of clinical development
- Broad understanding of clinical research processes, including study design, data analysis, and regulatory submission requirements
- Demonstrated ability to lead writing activities for complex documents and provide strategic input to cross-functional teams
- Excellent written and verbal communication skills, with the ability to clearly and accurately present complex scientific and clinical information
- Strong organizational, time management, and project management skills, with the ability to manage multiple priorities and meet tight deadlines
- High attention to detail with a commitment to quality, consistency, and scientific accuracy
- Proficiency in Microsoft Word and document formatting best practices
Desired Qualifications
- Advanced degree (e.g., MSc, PhD, PharmD, MD)
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