Medical, Legal and Regulatory (MLR) Coordinator
Core
Coordinates end-to-end Medical, Legal, and Regulatory (MLR) review processes for healthcare marketing content to ensure compliance and accuracy before publication.
Role type
MLR Coordinator (Program Management & Process Execution)
Builds
Compliant promotional and non-promotional healthcare content for dedicated clients
Domain
Healthcare / Pharmaceutical Marketing / Regulatory Compliance
Deliverable
client delivery
Required skills
MLR process management, meeting facilitation and minute-taking, Veeva Vault PromoMats/MedComms proficiency, scientific review, project management, regulatory submission support (FDA 2253)
Preferred skills
Pharmacy or Medicine degree, knowledge of global healthcare compliance statutes, US drug/device advertising regulations, medical terminology
Technologies
Veeva Vault PromoMats, Veeva Vault MedComms, Microsoft Office Suite, Outlook
Responsibilities
Manage end-to-end MLR process; schedule and lead Review Committee meetings; scribe meeting minutes and file approved documents; vet communications through review systems; QC final vs. approved documents; support FDA 2253 and country-specific regulatory submissions; support medical content development and project planning
Seniority
Mid-level, hands-on IC
