Senior Manager, Medical Information

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee and respond to timely, accurate, and balanced replies to unsolicited medical information requests from healthcare professionals, patients, caregivers, and internal stakeholders.

• Act as a subject matter expert in medical information for assigned products and disease areas.

• Collaborate with an outsourced medical information call center/vendor to facilitate inquiry fulfillment, training, escalation management, quality monitoring, and issue resolution.

• Manage the Medical Information (MIC) database from both a systems and operational perspective, including user access oversight, workflow configuration, data quality, reporting requirements, and documentation related to the system.

• Work with the medical information database/system vendor to identify, track, and resolve system bugs, enhancements, and operational needs that ensure compliant and effective inquiry management.

• Serve as a liaison with the outsourced call center to triage and resolve operational issues as they occur, including system access, workflow inquiries, inquiry routing, documentation, and escalation processes.

• Aid in the development, implementation, and ongoing improvement of Medical Information processes, work instructions, and operational standards to maintain consistency, compliance, and efficiency.

• Guarantee the proper identification and reporting of adverse events (AEs), product quality complaints, and special situations in collaboration with the Pharmacovigilance and Quality teams.

• Create, review, update, and maintain standard response documents (SRs), reactive materials (including payor documents), and scientific response content for both approved and pipeline products.

• Conduct research, analysis, and interpretation of scientific literature to support tailored medical responses and scientific dialogue.

• Lead and/or assist in crafting custom responses for intricate or escalated medical inquiries.

• Maintain version control and ensure that medical information content is up-to-date, scientifically balanced, and compliant.

• Work alongside Medical Affairs, Clinical Development, Regulatory, Legal/Compliance, Commercial, Market Access, and Safety colleagues to promote aligned and compliant medical information practices.

• Provide medical information insights and trends to bolster Medical Affairs strategy and enhance customer understanding.

• Ensure all activities comply with FDA regulations, company SOPs, and industry standards related to unsolicited medical requests and scientific exchange.

• Assist with Medical/Legal/Regulatory (MLR) review activities as needed and develop an understanding of promotional and non-promotional review processes.

⛳️ Requirements

• An advanced clinical or scientific degree is preferred (PharmD, PhD, NP, MD, or another relevant life sciences degree).

• A minimum of 5 years of experience in Medical Information, Medical Affairs, the pharmaceutical/biotechnology industry, or relevant clinical practice; experience in oncology, hematology, rare diseases, and/or payer environments is preferred.

• Experience with new product launches is preferred.

• Strong skills in medical writing and literature evaluation.

• Excellent communication and cross-functional collaboration abilities.

• Strong organizational skills and the capability to manage multiple priorities in a fast-paced environment.

• Knowledge of regulations and guidance related to unsolicited medical information requests and scientific exchange.

• Willingness to travel for internal meetings and scientific congresses (~15%).

🏝️ Benefits

• We cover 100% of medical, dental, and vision premiums for you and your family.

• Help reduce out-of-pocket expenses by funding up to 75% of in-network deductibles.

• 401(k) match with immediate vesting.

• Generous paid time off.

• 12 weeks of fully paid parental leave.

• Paid family and medical leave for all employees, regardless of location.

• Company-paid short-term disability coverage for up to 20 weeks.

• Additional perks include wellness programs, tuition reimbursement, and inclusive family-forming support.