Medical, Legal and Regulatory (MLR) Coordinator

About the role

The Medical, Legal and Regulatory (MLR) review is an essential process in healthcare marketing to ensure 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.

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/document discussion in live meetings.
• QC Final Document vs. Approved Document
• Support FDA 2253 submissions, or country specific regulatory submissions with MLR Regulatory Reviewer/Partner

Medical Content Support

• 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.

Qualifications

• Education: Graduates in any Life Sciences / Biomedical field.
• Must demonstrate excellent ability to communicate effectively in English, both orally and in writing.
• Experience and/or Training:
• At least 2 years of experience in a healthcare agency or pharmaceutical company
• Experience with use of Veeva Vault PromoMats / MedComms
• Experience in Scientific Writing / Scientific Reviewing / MLR
• Project management
• Time management
• Meeting management