Responsibilities

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.
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

Qualification

Strong working knowledge of UStrong project managementComfort developing dashboardsHigh degree of initiativeWork Location and ConditionsAt Amylyx

Required

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 preferred
Demonstrated 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 readiness, and continuous improvement
Experience using artificial intelligence-enabled tools or automation to improve workflow efficiency, meeting documentation, content operations, analytics, or quality control preferred, with a strong understanding of appropriate governance, confidentiality, and human oversight
High degree of initiative, judgment, curiosity, and comfort with ambiguity in a fast-paced, mission-driven environment preparing for a potential product launch
Work Location and Conditions
At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan and Tennessee.
You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.

Associate Director, MLR Governance and Fulfillment at Amylyx · LumiJobs

Associate Director, MLR Governance and Fulfillment

Responsibilities

Qualification

Required

Benefits

Company

Amylyx

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