MLR Governance Lead - Content Compliance & Ops

Amylyx Pharmaceuticals; Cambridge (MA); Hybrid; USD 184,000 - 207,000; Full time

Job summary

Amylyx Pharmaceuticals is seeking an Associate Director of Medical, Legal and Regulatory (MLR) Review Governance in the Cambridge, MA area. You will chair weekly MLR meetings and own the end-to-end approval workflow for promotional and external-facing materials.

The role demands 8+ years in life sciences MLR, strong cross-functional collaboration, and expertise in FDA/OPDP expectations, with a hybrid work arrangement in New England.

Qualifications

• Bachelor’s degree with 8+ years in life sciences MLR.
• Experience leading promotional/medical content review processes.
• Knowledge of FDA/OPDP expectations and labeling considerations.

Responsibilities

• Chair and coordinate weekly MLR review meetings, documenting decisions and actions.
• Own end-to-end content approval workflow across Medical, Legal, Regulatory and Compliance teams.
• Manage electronic content review system configuration, user roles, and audit trails.
• Collaborate with cross-functional teams to ensure truthful, balanced, substantiated materials.

Skills

MLR governance

cross-functional leadership

FDA/OPDP knowledge

project management

analytical skills

communication skills

dashboards/analytics

AI/app automation understanding

Education

Bachelor’s degree

Tools

Veeva PromoMats

Job description

Amylyx Pharmaceuticals is seeking an Associate Director of Medical, Legal and Regulatory (MLR) Review Governance in the Cambridge, MA area. You will chair weekly MLR meetings and own the end-to-end approval workflow for promotional and external-facing materials.

The role demands 8+ years in life sciences MLR, strong cross-functional collaboration, and expertise in FDA/OPDP expectations, with a hybrid work arrangement in New England.