Senior Director, Medical Information
GlobeNewswire
full-time
Posted on:
Location Type: Remote
Location: Massachusetts • United States
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Salary
💰 $230,000 - $285,000 per year
Job Level
About the role
- 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
- 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
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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 informationscientific writingregulatory compliancepharmacovigilancemedical affairsinquiry analysisquality indicatorsprocess buildingdocumentationresponse workflows
Soft Skills
leadershipcommunicationorganizational skillsattention to detailjudgmentcollaborationstrategic thinkingproblem-solvingadaptabilitycommitment to compliance
Certifications
Doctorate degree (MD, PhD, PharmD)