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GlobeNewswire

Senior Director, Medical Information

GlobeNewswire

Senior 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

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Applicant 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