Senior Manager, Medical Information

Cogent Biosciences

13d•$150,000 - $190,000•Hybrid

About The Position

The Senior Manager/Manager, Medical Information, will support the execution of medical information activities for Cogent Biosciences’ portfolio and pipeline programs. This individual will serve as a key scientific resource responsible for providing accurate, balanced, timely, and compliant medical information in response to unsolicited inquiries from healthcare professionals, patients, and internal stakeholders. This role will partner closely with Medical Affairs, Pharmacovigilance, Regulatory Affairs, Legal/Compliance, Commercial, and external medical information vendors/call centers to ensure high-quality scientific exchange and compliant dissemination of medical information. In partnership with the Senior Director Medical Information, this role will support Medical Information operations, including process optimization, system oversight, vendor coordination, and operational excellence for medical information workflows and tools. The ideal candidate is a strong scientific communicator with hands-on medical information experience, including inquiry response management, development of medical response content, medical information operations, and cross-functional collaboration in a fast-paced biotech environment.

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. 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%)

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.