Director, Medical Information
GlobeNewswire
full-time
Posted on:
Location Type: Office
Location: Waltham • Massachusetts • United States
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Salary
💰 $183,000 - $255,000 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.
- Ensure responses are scientifically accurate, balanced, up-to-date, and compliant with regulations.
- 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 10+ 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
scientific writingmedical information response documentsinquiry intakedocumentation workflowsresponse workflowsregulatory compliancepharmacovigilancedata analysismetrics monitoringquality indicators
Soft skills
communication skillsorganizational skillsprocess-building capabilitiesattention to detailcommitment to compliancescientific integrityjudgmentability to work in a matrixed environmentability to handle complex inquiriesleadership
Certifications
Doctorate degree (MD, PhD, PharmD)