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
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

Doctorate degree (MD, PhD, PharmD) with 1-5+ 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

Senior Director, Medical Information

Key skills