Medical, Legal and Regulatory (MLR) Coordinator

THE POSITION:

The Medical, Legal and Regulatory (MLR) review is an essential process in healthcare marketing to make sure advertising, promotional and non-promotional content is accurate, compliant, and ready to be published. The MLR process must rigorously control and execute review, approval and document filing actions. As part of the MLR team, the Medical, Legal and Regulatory (MLR) Coordinator is responsible for managing all the MLR processes for a dedicated client. The Medical, Legal and Regulatory (MLR) Coordinator ensures that all administrative and program management support for the client’s MLR process operates effectively and in full compliance with all internal and external policies and regulations. 

ESSENTIAL DUTIES AND RESPONSIBILITIES:
Our employees are tasked with delivering excellent business results through the efforts of their teams.  These results are achieved by:

MEDICAL, LEGAL AND REGULATORY (MLR) COORDINATOR RESPONSIBILITIES

• Manages the end-to-end MLR process.
• Responsible for scheduling, setting the agenda, and leading Review Committee meetings.
• Add live discussion notes for comments discussed in Veeva Vault
• Scribe meeting minutes, circulate draft meeting minutes for Committee approval and finalize and file approved minutes
• Ensure all covered communications are properly vetted through the review process utilizing the online review system (e.g., Veeva Vault PromoMats and Vault MedComms)
• Cascade and enforce any new policies and guidelines related to review of materials.
• Verifies that materials are assigned to the appropriate review path. Rejects incomplete submissions and materials that are not review ready. Facilitates/documents discussion in live meetings.
• QCs Final Document vs. Approved Document
• Supports FDA 2253 submissions, or country specific regulatory submissions with MLR Regulatory Reviewer/Partner

MEDICAL CONTENT SUPPORT RESPONSIBILITIES

• Support the development of project plans
• Support medical content development team
• Support upload of materials into clients’ review and approval platforms, including supporting annotating, anchoring references, etc.

MEDICAL AFFAIRS AND MEDICAL INFORMATION PROJECT MANAGEMENT SUPPORT

• Support Medical Affairs and Medical Information leadership in developing and managing project plans for key initiatives
• Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias.
• All other duties as assigned.

Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by an employee with a disability, unless such accommodation would cause an undue hardship for EVERSANA. If reasonable accommodation is needed to perform the essential functions of your job position, please contact Human Resources.

EXPECTATIONS OF THE JOB:

• Travel: In general, this position does not travel.
• Hours: Able to work full-time and be flexible with work scheduling as required by clients and management.
• Metrics: Maintain and contribute toward process improvement which positively impacts metrics associated with activities of the MLR Review process; metrics are subject to change annually or more often as deemed necessary.
• Customer Services: Maintain and improve customer services associated with the activity of the MLR review.
• Time Management: Complete MLR coordination responsibilities in a timely manner.

The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position.

An individual in this position must be able to successfully perform the expectations listed above.