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Senior Director, Medical Information
GlobeNewswireSenior Director at Dyne Therapeutics leading medical information for neuromuscular diseases. Establishing scalable infrastructures and ensuring compliance in medical inquiries and documentation.
Posted 6/29/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesSenior💰 $230,000 - $295,000 per yearWebsite
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- 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
Benefits
Comp & perks- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Medical Information StrategyInquiry Intake ManagementResponse Document DevelopmentMLR Review OversightPharmacovigilance Requirements
Soft Skills
Attention to DetailJudgment in Complex InquiriesVerbal Communication Skills