Associate Director, Medical Information and Review
Core
Lead Medical Information and Review operations to ensure scientific accuracy, integrity, and fair balance in promotional and non-promotional materials for neuromuscular disease therapeutics.
Role type
Senior IC Medical Information Director
Builds
Scalable Medical Information processes, content libraries, and operational workflows for product launch readiness
Domain
Biotechnology / Neuromuscular Diseases
Required skills
Medical reviewer for promotional/non-promotional materials, FDA regulations and compliance, Medical Information response document development, medical literature search and evidence synthesis, cross-functional stakeholder collaboration, process building and SOP development
Preferred skills
Launch readiness and Medical Information operations, vendor/contact center oversight, congress activities and insights analysis, rare disease or neuromuscular disease experience
Technologies
None stated
Responsibilities
Serve as core Medical Affairs reviewer in Medical, Legal, and Regulatory review committees; Establish and maintain subject matter expertise on Dyne's neuromuscular disease product portfolio; Build scalable processes and content libraries for product lifecycle support; Oversee day-to-day Medical Information inquiry handling and vendor activities; Analyze inquiry trends and congress insights to provide actionable recommendations; Ensure compliance with FDA regulations and Medical Affairs best practices; Lead workstreams to improve Medical Information operations and inspection readiness
Seniority
Senior, hands-on IC with leadership responsibilities