Cristcot Management Company INC

Medical, Legal & Regulatory (MLR) Specialist

Remote (United States)

Sponsorship not specifiedDetected 14 days ago

Project ManagementStakeholder ManagementProcess ImprovementFDA RegulatoryLeadershipCommunicationCollaborationOrganizational SkillsRegulatory Affairs

About the role

This role serves as a central point of coordination for promotional review activities, ensuring materials are reviewed, approved, documented, and archived in accordance with FDA regulations, company policies, and industry best practices.

The MLR Coordinator will collaborate with external agency partners to ensure materials are reviewed efficiently, compliantly, and within established timelines.
Outside Cristcot: The MLR Coordinator will collaborate with external agency partners to ensure materials are reviewed efficiently, compliantly, and within established timelines.
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.
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.
Compliance Documentation & Systems Management Maintain promotional review systems, approval workflows, records, and documentation repositories.
Maintain audit-ready records for all promotional review activities and approvals.
Support licensing and access management for content review platforms, including Vodori, Veeva, and related systems.
Partner with leadership to implement corrective actions and workflow enhancements.

Coordinate MLR review meetings and ensure timely routing of materials to designated reviewers.
Track review status, approvals, reviewer comments, revision cycles, and final disposition of materials.
Ensure proper version control and archival of approved materials and supporting documentation.
Coordinate updates and maintenance activities to ensure content is current and compliant.
Process Management & Compliance Oversight Ensure promotional and communication materials adhere to FDA regulations, industry guidelines, company policies, and applicable compliance standards.
Monitor review timelines and identify bottlenecks or process gaps affecting review efficiency.
Assist in the development, revision, and maintenance of Standard Operating Procedures (SOPs), work instructions, and training documentation.
3-7+ years of experience supporting MLR/PRC operations, promotional review, regulatory operations, compliance, or pharmaceutical marketing processes.

Partner with Medical Affairs teams to ensure appropriate submission ownership and coordination of review materials.

About Cristcot We are in the business of addressing the problem within the problem.
We focus on the details and connections that other, major pharma companies have left ignored for years.
There are better ways, better drugs and better formulations and we will make them a reality by analyzing, understanding and solving the problems within the problems.
Job Summary We are seeking a highly organized and accountable MLR Coordinator for the operational management, coordination, and continuous improvement of the Medical, Legal, and Regulatory (MLR) review process across Marketing, Medical Affairs, and Corporate Communications.

This listing is sourced directly from Cristcot Management Company INC's careers page and normalized into a canonical job model.