Associate Director, Medical Information, Medical Review

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

📋 Description

• Develop Medical Information capabilities, which include response standards, scalable processes, and readiness plans that align with Medical Affairs priorities, regulatory milestones, and potential product launches.

• Act as a reliable scientific and clinical resource for inquiries related to vidofludimus calcium, multiple sclerosis, and Immunic’s pipeline.

• Create processes for the intake, triage, documentation, response, escalation, and analysis of unsolicited medical and scientific inquiries.

• Design and maintain Medical Information resources, such as standard response documents, FAQs, medical information letters, and personalized responses.

• Collaborate with Medical Affairs Operations and external vendors or contact centers on response delivery, training, quality oversight, issue escalation, and performance monitoring.

• Work alongside Pharmacovigilance and Quality to identify and escalate adverse events, product complaints, and other reportable information.

• Analyze inquiry trends and insights from Medical Information to inform Medical Affairs planning, congress readiness, field resources, and scientific communication priorities.

• Serve as a senior medical reviewer for both promotional and non-promotional materials.

• Assess 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 along with their communication.

• Provide risk-based medical review comments and collaborate cross-functionally to resolve issues and support timely approvals.

• Establish standards for Medical Review, along with guidance, documentation practices, escalation pathways, and quality controls.

• Develop SOPs, work instructions, templates, content standards, and controlled processes in collaboration with Medical Affairs Operations, Quality, Regulatory Affairs, and Legal and Compliance.

• Define scientific and business requirements for systems, vendors, metrics, and workflows.

• Translate priorities from Medical Affairs into scientific deliverables and readiness milestones that support late-stage development, regulatory submissions, and potential launches.

• Identify risks, suggest solutions, and appropriately escalate significant issues.

⛳️ Requirements

• PharmD, MD, PhD, or another relevant advanced scientific or clinical degree, along with relevant experience.

• A minimum of six years of progressive experience in Medical Information, Medical Review, Medical Communications, Medical Affairs, or a closely related field within the biotechnology or pharmaceutical industry.

• Practical experience in developing and maintaining standard response documents, FAQs, medical information letters, custom scientific responses, or similar Medical Information resources.

• Experience in responding to unsolicited medical and scientific inquiries from healthcare professionals, patients, or other external stakeholders.

• Experience in conducting medical reviews of promotional and/or non-promotional materials within a cross-functional review process.

• Outstanding scientific writing, literature interpretation, evidence evaluation, and medical review capabilities.

• 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 appropriately escalate issues.

• Strong organizational skills, with the ability to manage high-quality scientific deliverables across multiple priorities.

• Experience working with project management, operations, vendor, or systems teams is preferred.

• Comfortable operating within a growing, pre-commercial biotechnology organization where processes are being established and priorities may shift.

🏝️ Benefits

• Equity

• Bonus

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