Associate Director, Medical Information, Medical Review

🔥 39 minutes ago

🇺🇸 United States – Remote

💵 $170k - $210k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 0%

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Immunic Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2016

🏥 Healthcare

💼 Consulting

⚖️ Legal

Healthcare • Consulting • Legal

Immunic Therapeutics is a late-stage biotechnology company focused on developing novel, orally administered small-molecule therapies for chronic inflammatory and autoimmune diseases, with particular programs targeting multiple sclerosis and celiac disease. The company advances differentiated clinical-stage programs (e. g. , vidofludimus calcium, IMU-856, IMU-381) aiming to provide efficacious, safe, and well-tolerated oral treatment options for neurologic and gastrointestinal immune-mediated conditions, while pursuing regulatory protections and commercialization pathways.

📋 Description

• Build Medical Information capabilities, including response standards, scalable processes, and readiness plans aligned with Medical Affairs priorities, regulatory milestones, and potential launch • Serve as a trusted scientific and clinical resource for inquiries regarding vidofludimus calcium, multiple sclerosis, and Immunic’s pipeline • Establish processes for intake, triage, documentation, response, escalation, and analysis of unsolicited medical and scientific inquiries • Develop and maintain Medical Information resources, including standard response documents, FAQs, medical information letters, and custom responses • Partner with Medical Affairs Operations and external vendors or contact centers on response delivery, training, quality oversight, issue escalation, and performance monitoring • Partner with Pharmacovigilance and Quality to identify and escalate adverse events, product complaints, and other reportable information • Analyze inquiry trends and Medical Information insights to inform Medical Affairs planning, congress readiness, field resources, and scientific communication priorities • Serve as senior medical reviewer for promotional and non-promotional materials • Evaluate materials for scientific and clinical accuracy, balance, context, evidence support, and alignment with product development or labeling status • Review clinical, safety, statistical, mechanistic, and health-outcomes data and their communication • Provide risk-based medical review comments and partner cross-functionally to resolve issues and support timely approval • Establish Medical Review standards, guidance, documentation practices, escalation pathways, and quality controls • Develop SOPs, work instructions, templates, content standards, and controlled processes with Medical Affairs Operations, Quality, Regulatory Affairs, and Legal and Compliance • Define scientific and business requirements for systems, vendors, metrics, and workflows • Translate Medical Affairs priorities into scientific deliverables and readiness milestones supporting late-stage development, regulatory submission, and potential launch • Identify risks, recommend solutions, and escalate significant issues appropriately

🎯 Requirements

• PharmD, MD, PhD, or another relevant advanced scientific or clinical degree with relevant experience • At least six years of progressive experience in Medical Information, Medical Review, Medical Communications, Medical Affairs, or a closely related function within the biotechnology or pharmaceutical industry • Hands-on experience developing and maintaining standard response documents, FAQs, medical information letters, custom scientific responses, or similar Medical Information resources • Experience responding to unsolicited medical and scientific inquiries from healthcare professionals, patients, or other external stakeholders • Experience conducting medical review of promotional and/or non-promotional materials within a cross-functional review process • Exceptional scientific writing, literature interpretation, evidence evaluation, and medical review skills • Working knowledge of applicable requirements and industry standards governing Medical Information, scientific exchange, responses to unsolicited inquiries, medical review, and pre-approval and promotional communications • Experience partnering with Medical Affairs, Clinical Development, Regulatory Affairs, Legal and Compliance, Pharmacovigilance, Commercial, and external service providers • Ability to exercise independent judgment, identify and manage risk, make well-reasoned recommendations, and escalate issues appropriately • Strong organizational skills and ability to manage high-quality scientific deliverables across multiple priorities • Experience partnering with project-management, operations, vendor, or systems teams is preferred • Comfort operating in a growing, pre-commercial biotechnology organization where processes are being developed and priorities may evolve

🏖️ Benefits

• Equity • Bonus • Equal Opportunity Employer commitment to a diverse, inclusive, and equitable workplace

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