Senior Manager, Medical Information

• Respond to and oversee timely, accurate, and balanced responses to unsolicited medical information inquiries from healthcare professionals, patients, caregivers, and internal stakeholders.
• Serve as a medical information subject matter resource for assigned products and disease states.
• Partner with outsourced medical information call center/vendor to support inquiry fulfillment, training, escalation management, quality monitoring, and issue resolution.
• Manage the Medical Information (MIC) database from a system and operations standpoint, including oversight of user access, workflow configuration, data quality, reporting needs, and system-related documentation.
• Partner with the medical information database/system vendor to identify, track, and resolve system bugs, fixes, enhancements, and other operational needs that support compliant and efficient inquiry management.
• Serve as a liaison with the outsourced call center to triage and resolve operational issues as they arise, including system access, workflow questions, inquiry routing, documentation, and escalation processes.
• Support development, implementation, and continuous improvement of Medical Information processes, work instructions, and operational standards to ensure consistency, compliance, and efficiency.
• Ensure appropriate identification and reporting of adverse events (AEs), product quality complaints, and special situations in partnership with Pharmacovigilance and the Quality team.
• Develop, review, update, and maintain standard response documents (SRs), reactive materials (including payor materials), and scientific response content for approved and pipeline products.
• Research, analyze, and interpret scientific literature to support custom medical responses and scientific exchange.
• Lead and/or support development of custom responses for complex or escalated medical inquiries.
• Maintain version control and ensure medical information content remains current, scientifically balanced, and compliant.
• Collaborate with Medical Affairs, Clinical Development, Regulatory, Legal/Compliance, Commercial, Market Access and Safety colleagues to support aligned and compliant medical information practices.
• Contribute medical information insights and trends to support Medical Affairs strategy and customer understanding.
• Ensure activities comply with FDA regulations, company SOPs, and industry standards governing unsolicited medical requests and scientific exchange.
• Support Medical/Legal/Regulatory (MLR) review activities as needed and develop understanding of promotional and non-promotional review processes.

Qualifications:

Advanced clinical or scientific degree preferred (PharmD, PhD, NP, MD, or other relevant life sciences degree).

• 5+ years of experience in Medical Information, Medical Affairs, pharmaceutical/biotechnology industry, or relevant clinical practice experience; oncology, hematology, rare disease and/or payor experience preferred.
• New product launch experience preferred
• Strong medical writing and literature evaluation skills. And the ability to communicate complex scientific information.
• Excellent communication and cross-functional collaboration skills.
• Strong organizational skills and ability to manage multiple priorities in a fast-paced environment.
• Understanding of regulations and guidance related to unsolicited medical information requests and scientific exchange.
• Ability to travel to internal meetings and scientific congresses (~15%)

Salary Range:

$150,000 - 190,000 USD