Associate Director, MLR Governance

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people. Our core values - be audacious, be curious, be authentic, be engaged, and be accountable - creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine's toughest problems, we encourage you to read the opportunity below and apply. The Opportunity Reporting into the Vice President, Commercial Operations, the Associate Director, Medical, Legal and Regulatory Review Governance will lead Amylyx's Medical, Legal and Regulatory (MLR) review governance process for promotional, disease education, patient, healthcare professional, and other external-facing content. This highly cross-functional role will chair the once-weekly MLR review meeting and serve as the operational owner of the review process, helping ensure that materials developed by Marketing and other content-generating teams are reviewed, approved, documented, and distributed in a compliant, efficient, and audit-ready manner. Responsibilities Chair and facilitate the weekly MLR review meeting, including agenda development, meeting administration, decision documentation, follow-up tracking, and clear communication of review outcomes to content owners and cross-functional reviewers Own the end-to-end promotional and external content approval workflow across Medical, Legal, Regulatory, Compliance, Commercial Operations, Marketing, and other stakeholder groups, ensuring materials are routed, reviewed, approved, and archived in accordance with company standards Partner with IT to administer and maintain Amylyx's electronic content review system, including workflow configuration, reviewer assignments, status tracking, version control, metadata quality, audit trails, and process documentation Partner with Medical, Legal, Regulatory, Compliance, Commercial, Market Access, Patient Services, agencies, and other content-generating teams to support timely, high-quality review of materials intended for healthcare professionals, patients living with PBH, caregivers, and other external stakeholders Help ensure outbound communications remain truthful, balanced, accurate, appropriately substantiated, and aligned with applicable FDA/OPDP expectations, 21 CFR Part 202 requirements, approved labeling, company policies, and relevant industry standards Develop, maintain, and continuously improve MLR governance processes, including SOPs, work instructions, review standards, escalation pathways, reviewer training, launch-readiness processes, and inspection-ready documentation Consolidate and deliver analytics related to review volume, cycle times, approval timelines, bottlenecks, content types, reviewer workload, rework trends, and process performance to inform leadership decisions and improve operational efficiency Identify appropriate opportunities to use artificial intelligence responsibly within the MLR workflow, such as meeting preparation, minutes drafting, workflow triage, metadata tagging, completeness checks, analytics, trend detection, and process automation, while maintaining human review, confidentiality, compliance controls, and auditability Required Qualifications Bachelor's degree with 8+ years of relevant experience in life sciences MLR. Meaningful experience supporting Medical, Legal and Regulatory review, promotional review committees, commercial operations, regulatory affairs, medical affairs, compliance, or related governance processes Strong working knowledge of U.S. prescription drug promotion requirements, FDA/OPDP expectations, fair balance, risk communication, substantiation standards, approved labeling considerations, and internal promotional review controls Experience administering or optimizing an electronic content review, digital asset management, or promotional materials workflow system; experience with Veeva PromoMats or a similar platform preferredDemonstrated ability to lead cross-functional meetings, manage agendas and minutes, track decisions and action items, and drive accountability across senior and peer stakeholders Strong project management, process improvement, analytical, and communication skills, with the ability to translate complex governance requirements into clear, practical ways of working Comfort developing dashboards, metrics, and executive-ready insights related to workflow performance, operational risk, launch r #J-18808-Ljbffr amylyx