Senior Director, Medical Information

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Establish and lead the medical information function, encompassing strategy, processes, and execution.

• Create a scalable medical information infrastructure, which includes inquiry intake, documentation, and response workflows.

• Oversee the implementation and training of the medical inquiry intake portal and call center vendors, while managing relationships moving forward.

• Develop high-quality medical information response documents (such as standard response letters, FAQs, and backgrounders) and maintain medical information content in alignment with product labeling, clinical data, and evolving scientific evidence.

• Lead and supervise Medical, Legal, and Regulatory (MLR) review processes.

• Ensure that responses are scientifically accurate, balanced, current, 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 guarantee continuous improvement and compliance.

⛳️ Requirements

• 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 in establishing or leading a medical information function is highly preferred.

• Strong understanding of regulatory, compliance, and pharmacovigilance requirements.

• Excellent scientific writing and verbal communication skills.

• Strong organizational skills and capabilities in process building.

• Exceptional attention to detail and a commitment to compliance and scientific integrity.

• Ability to perform effectively in a matrixed, fast-paced biotech environment.

• Strong judgment in managing complex or sensitive inquiries.

🏝️ Benefits

• Health insurance.

• 401(k) matching.

• Flexible work hours.

• Paid time off.

• Remote work options.