Senior Manager, Medical Information
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Job Description
Senior Manager managing medical information activities for Cogent Biosciences' portfolio and pipeline programs. Providing accurate, balanced, timely, and compliant medical information responses.
Responsibilities:
- 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
Requirements:
- 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
- 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%)
Benefits:
- We cover 100% of medical, dental, and vision premiums for you and your family
- Help reduce out-of-pocket costs 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 like wellness programs, tuition reimbursement, and inclusive family-forming support
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