Back to jobs
New

Associate Director, MLR Governance

Cambridge, MA

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 LinkedIn.

To return to our website please click here.

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.

Create a Job Alert

Interested in building your career at Amylyx Pharmaceuticals? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Select...
Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Amylyx Pharmaceuticals’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 07/31/2029

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.