Medical, Legal & Regulatory (MLR) Specialist

Location: Remote (United States)

Department: 2503 Marketing Communications

Job Summary

We are seeking a highly organized and accountable MLR Specialist 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 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.

Primary Relationships: 

• Within Cristcot: The MLR Specialist will partner cross-functionally with Medical Affairs, Regulatory Affairs, Legal, Compliance, Commercial, and Marketing. 
• Outside Cristcot: The MLR Specialist will collaborate with external agency partners to ensure materials are reviewed efficiently, compliantly, and within established timelines. 

Primary Job Responsibilities

The position partners closely with cross-functional stakeholders, including Marketing, Medical Affairs, Regulatory Affairs, Legal, Compliance, Corporate Communications, external agencies, and content management teams to facilitate efficient review workflows, maintain compliance documentation, support audit readiness, and drive process optimization initiatives.

The activities of the MLR Specialist will include, but are not limited to: 

Promotional Review Operations

• 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.

Compliance Documentation & Systems Management

• Maintain promotional review systems, approval workflows, records, and documentation repositories.
• 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
• Ensure approved content is accurately maintained across applicable content management platforms and repositories.
• Coordinate updates and maintenance activities to ensure content is current and compliant.
• Support licensing and access management for content review platforms, including Vodori, Veeva, and related systems.

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.
• Partner with leadership to implement corrective actions and workflow enhancements.
• Generate and distribute MLR metrics, dashboards, and reporting to support business and compliance objectives.
• Assist in the development, revision, and maintenance of Standard Operating Procedures (SOPs), work instructions, and training documentation.
• Conduct training sessions for internal teams, external agencies, and business partners on promotional compliance requirements and MLR best practices.
• Drive status reporting, risk identification, and issue resolution activities to keep leadership informed and key launch initiatives on track.
• Work with management to define, document, and continuously improve Promotional Review Committee (PRC) processes, including submission workflows, review timelines, approval pathways, escalation protocols
• Monitor FDA guidance, enforcement actions, and industry trends to proactively recommend adjustments to communication and review practices.

Skills and Qualifications

• 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.

About the Company

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.