Senior Director, Medical Information
New
This position is based in Waltham, MA, with the option to work remotely.Full-TimeDirector
Salary230,000 - 295,000 USD per year
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Job Details
- Experience
- 15+ years
- Required Skills
- Process improvement
Requirements
- Doctorate degree (MD, PhD, PharmD).
- 15+ years of experience in medical information or medical affairs in rare diseases, neuromuscular diseases, or a related field.
- 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 scientific integrity.
- Ability to work effectively in a matrixed, fast-paced biotech environment.
- Strong judgment in handling complex or sensitive inquiries.
- Experience establishing or leading a medical information function is strongly preferred.
Responsibilities
- Establish and lead the medical information function, including strategy, processes, and execution.
- Build 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.
- Develop high-quality medical information response documents, such as standard response letters and FAQs, ensuring alignment with product labeling and clinical data.
- Lead and oversee Medical, Legal, and Regulatory (MLR) review processes.
- Ensure all responses are scientifically accurate, balanced, and compliant with regulations.
- Coordinate the escalation of safety, quality, and off-label inquiries.
- Analyze inquiry trends to identify knowledge gaps and inform broader medical strategy.
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