Medical Legal & Regulatory Coordinator

This is a fully remote position, open to applicants in United States.

📋 Description

• Supervise and manage MLR review and approval submissions for Marketing, Medical Affairs, and Corporate Communications materials.

• Collaborate with Medical Affairs teams to ensure proper submission ownership and coordination of review materials.

• Organize MLR review meetings and guarantee timely distribution of materials to designated reviewers.

• Maintain and oversee the Master MLR Review Schedule across all business functions.

• Create, update, and communicate a weekly MLR 'Hot Sheet' that highlights all active and upcoming review activities needing approval.

• Monitor review status, approvals, reviewer feedback, revision cycles, and the final disposition of materials.

• Work with agencies, content creators, and internal library resources to ensure that supporting references, journal articles, and documentation are accurately maintained within Zotero and related content repositories.

• Collaborate with leadership to identify workflow efficiencies and suggest process enhancements to improve review timelines and stakeholder experiences.

• Ensure proper version control and archiving 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.

• Produce and distribute MLR metrics, dashboards, and reports to support business and compliance goals.

• 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 in supporting MLR/PRC operations, promotional review, regulatory operations, compliance, or pharmaceutical marketing processes.

• Familiarity with FDA promotional regulations, OPDP requirements, and compliance standards within the pharmaceutical industry.

• Experience with promotional review systems such as Veeva PromoMats, Vodori, or similar platforms.

• Strong project management, organizational, and coordination abilities.

• Exceptional attention to detail and capabilities in documentation management.

• Capacity to handle multiple projects simultaneously in a fast-paced environment.

• Strong communication, collaboration, and stakeholder management skills.

• Experience in supporting Medical Affairs, Commercial, and Corporate Communications review processes is preferred.

• Knowledge of content management systems, reference libraries, and citation management tools like Zotero is preferred.

• Experience in developing compliance metrics, dashboards, and reports is preferred.

• Familiarity with audit readiness and inspection support activities is preferred.

• Project management certification or formal process improvement training is a plus.

• Ability to support meetings across multiple U.S. time zones.

• Occasional travel may be required for team meetings, launch activities, or training.

🏝️ Benefits

• Flexible working hours