Director of After School Programs at Camp Fire Alaska empowering youth through community programs and partnerships. Leading teams and ensuring quality across after - school initiatives in Anchorage, Alaska.
About the role
- Director, Medical Information leading the function for delivering compliant scientific responses. Overseeing medical inquiry structure and ensuring high-quality medical information in biotech.
Responsibilities
- 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 going forward.
- Develop high-quality medical information response documents (standard response letters, FAQs, backgrounders) and maintain medical information content aligned with product labeling, clinical data, and evolving scientific evidence.
- Ensure responses are scientifically accurate, balanced, up-to-date, and compliant with regulations.
- 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.
Requirements
- Doctorate degree (MD, PhD, PharmD) with 10+ years of experience in medical information or medical affairs in rare diseases, neuromuscular diseases, or a related field
- Experience establishing or leading a medical information function is strongly preferred
- Strong understanding of regulatory, compliance, and pharmacovigilance requirements
- Excellent scientific writing and verbal communication skills
- Strong organizational and process-building capabilities
- High attention to detail and commitment to compliance and scientific integrity
- Ability to work effectively in a matrixed, fast-paced biotech environment
- Strong judgment in handling complex or sensitive inquiries
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