Medical Legal & Regulatory Coordinator

Role Overview

• Oversee and manage MLR review and approval submissions for Marketing, Medical Affairs, and Corporate Communications materials.
• Partner with Medical Affairs teams to ensure appropriate submission ownership and coordination of review materials.
• Coordinate MLR review meetings and ensure timely routing of materials to designated reviewers.
• Maintain and manage the Master MLR Review Schedule across all business functions.
• Develop, maintain, and communicate a weekly MLR 'Hot Sheet' highlighting all active and upcoming review activities requiring approval.
• Track review status, approvals, reviewer comments, revision cycles, and final disposition of materials.
• Collaborate with agencies, content creators, and internal library resources to ensure supporting references, journal articles, and documentation are appropriately maintained within Zotero and related content repositories.
• Partner with leadership to identify workflow efficiencies and recommend process improvements to enhance review timelines and stakeholder experience.
• Ensure proper version control and archival of approved materials and supporting documentation.
• Maintain audit-ready records for all promotional review activities and approvals.
• Manage tracking systems for FDA submissions, OPDP correspondence, advisory comments, approval records, version histories and compliance documentation
• Generate and distribute MLR metrics, dashboards, and reporting to support business and compliance objectives.
• Conduct training sessions for internal teams, external agencies, and business partners on promotional compliance requirements and MLR best practices.

Requirements

• Bachelor’s degree in Life Sciences, Business, Marketing, Communications, Healthcare Administration, or a related field.
• 3–7+ years of experience supporting MLR/PRC operations, promotional review, regulatory operations, compliance, or pharmaceutical marketing processes.
• Working knowledge of FDA promotional regulations, OPDP requirements, and pharmaceutical industry compliance standards.
• Experience with promotional review systems such as Veeva PromoMats, Vodori, or similar platforms.
• Strong project management, organizational, and coordination skills.
• Excellent attention to detail and documentation management capabilities.
• Ability to manage multiple projects simultaneously in a fast-paced environment.
• Strong communication, collaboration, and stakeholder management skills.
• Experience supporting Medical Affairs, Commercial, and Corporate Communications review processes preferred.
• Knowledge of content management systems, reference libraries, and citation management tools such as Zotero preferred.
• Experience developing compliance metrics, dashboards, and reporting preferred.
• Familiarity with audit readiness and inspection support activities preferred.
• Project management certification or formal process improvement training is a plus.
• Ability to support meetings across multiple U.S. time zones.
• May require occasional travel for team meetings, launch activities, or training.

Benefits

• Flexible working hours