Director, MLR Governance

amylyx

Cambridge (MA)

On-site

USD 150,000 - 190,000

Full time

7 days ago
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Job summary

Amylyx seeks an Associate Director, Medical, Legal and Regulatory Review Governance to lead the MLR governance process for promotional and external content. The role chairs the weekly MLR meeting and oversees end-to-end review, approval, and archival workflows across Medical, Legal, Regulatory, Compliance, Marketing and related teams.

The candidate will partner with IT to manage the content review system, ensure audit-ready documentation, and drive efficiency while maintaining regulatory and

Qualifications

  • Bachelor's degree and 8+ years in life sciences MLR
  • Experience supporting Medical, Legal and Regulatory review and related governance
  • Knowledge of U.S. prescription drug promotion requirements and FDA/OPDP expectations
  • Experience with electronic content review workflows; Veeva PromoMats preferred
  • Ability to lead cross-functional meetings, manage agendas and decisions
  • Strong project management, analytics, and communication skills

Responsibilities

  • Chair weekly MLR review meeting and document decisions
  • Own end-to-end content approval workflow across stakeholders
  • Administer and maintain the content review system and workflows
  • Collaborate with content-generating teams to ensure timely reviews
  • Ensure outbound communications meet FDA/OPDP and labeling requirements
  • Develop and improve MLR governance SOPs, instructions, and documentation
  • Provide analytics on review volume, cycle times, and bottlenecks
  • Explore responsible AI opportunities within MLR while maintaining governance

Skills

Cross-functional leadership
Project management
Regulatory affairs knowledge
Analytical skills
Communication
Stakeholder management

Education

Bachelor's degree in life sciences or related field

Tools

Veeva PromoMats
Electronic content review system
Digital asset management

Job description

Amylyx seeks an Associate Director, Medical, Legal and Regulatory Review Governance to lead the MLR governance process for promotional and external content. The role chairs the weekly MLR meeting and oversees end-to-end review, approval, and archival workflows across Medical, Legal, Regulatory, Compliance, Marketing and related teams.

The candidate will partner with IT to manage the content review system, ensure audit-ready documentation, and drive efficiency while maintaining regulatory and

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