- Establish and lead the medical information function, including strategy, processes, and execution
- Establish scalable medical information infrastructure, including inquiry intake, documentation, and response workflows
- Oversee the implementation and training of the medical inquiry intake portal and call center vendors and manage relationships
- Develop high-quality medical information response documents (standard response letters, FAQs, backgrounders) and maintain medical information content
- Lead and oversee Medical, Legal, and Regulatory (MLR) review
- Ensure responses are scientifically accurate, balanced, up-to-date, and compliant with regulation
- Ensure appropriate escalation and coordination of safety, quality, and off-label inquiries
- Analyze inquiry trends to identify knowledge gaps, unmet medical needs, and opportunities to inform medical strategy
- Monitor metrics and quality indicators to ensure continuous improvement and compliance
Process improvement