Associate Director, MLR Governance

Role: Associate Director, Medical, Legal and Regulatory Review Governance, overseeing Amylyx’s cross-functional MLR review process for external content. Responsibilities: chair weekly review meetings, manage end-to-end approval workflows across Medical, Legal, Regulatory, Compliance, and Commercial teams, and optimize use of electronic review systems (preferably Veeva PromoMats). Partner with diverse stakeholders to ensure truthful, compliant, and balanced materials for healthcare professionals, patients, and caregivers; develop and improve governance SOPs, track review metrics, and leverage AI responsibly for workflow efficiency. Requirements: Bachelor’s degree with 8+ years in life sciences MLR, with experience supporting Medical, Legal, Regulatory review, promotional review committees, or governance processes. Deep knowledge of U.S. prescription drug promotion regulations, FDA/OPDP standards, and experience with digital content review tools. Skills include cross-functional leadership, project management, process optimization, analytics, and communication. Preferred: experience with AI tools, platform optimization, and working in a fast-paced, mission-driven environment preparing for product launch. Location: Hybrid in Cambridge, MA, with travel to the office several times a year. High-value biopharma aspects: focus on compliant external content review in a clinical-stage biotech, with emphasis on FDA compliance, digital content management, and cross-functional collaboration in a regulated environment.