Associate Director, MLR Governance Amylyx Pharmaceuticals - 5.0 Cambridge, MA Job Details $184,000 - $207,000 a year 3 hours ago Qualifications Meeting minutes Performance dashboard reports Project reporting Dashboard development Tooling Pharmaceutical regulatory compliance Drug regulation Dashboard creation support Metrics Reporting Bachelor's degree Quality improvement Data analytics Leading team collaboration initiatives Meeting facilitation Management reporting Operational excellence initiatives Video conferences (communication methods) Process improvement planning Medical affairs Project leadership Cross-functional team management Project stakeholder communication Cross-functional communication FDA regulations Full Job Description 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. The role will be hybrid in Amylyx's Cambridge, MA office, with preference for candidates located in New England. 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 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. You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location. Compensation The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate's experience, skills, and qualifications, as well as considerations of internal equity. Estimated Pay Range $184,000 - $207,000 USD To stay connected with us, follow Amylyx Pharmaceuticals on Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx's management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.