Senior Director, Medical Information

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🔥 1 minute ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $230k - $295k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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GlobeNewswire

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Built for PR, IR,marketing and agency professionals, GlobeNewswire by Notified gives you a wide range of options to help you build brand awareness, reach new audiences, and drive earned media.GlobeNewswire distributes press releases and multimedia content on behalf of thousands of customers every year, including growing businesses, agencies, non-profits, and many of the world’s largest public companies. We have options to fit your specific needs and budget, and editorial services that are second to none.Visit GlobeNewswire.com to learn more.

📋 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

🎯 Requirements

• 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

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options