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Senior Director, Medical Information

DirectorDirectorFull TimeRemoteSeniorTeam 1,001-5,000H1B No SponsorCompany SiteLinkedIn

Location

Massachusetts

Posted

5 days ago

Salary

$230K - $285K / year

Seniority

Senior

Postgraduate Degree15 yrs expEnglish

Job Description

• 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

Job Requirements

  • Doctorate degree (MD, PhD, PharmD) with 15+ 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

  • NA

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