MLR Review Coordinator

About the Job

The MLR Coordinator will be responsible for end-to-end management of all aspects of the MLR process and activities tracking as per the calendar, and will work cross-functionally between Marketing, Commercial, Regulatory, Legal, Compliance, Labeling, Medical Affairs and Business Operations teams, vendors and agency partners. The MLR Coordinator will prioritize, execute, and disseminate promotional and Non-promotional material to respective stakeholders, and facilitate the MLR review process and approvals. This role will require collaboration and tactical management of MLR activities to ensure effective and efficient adherence to standard operating procedures (SOPs).

Job description

• Manages the end-to-end MLR (Medical, Legal, and Regulatory) review process in alignment with Promotional Review Committee (PRC)/Medical Review Committee (MRC), ensuring timely review of advertising, promotional, and non-promotional materials.

• Acts as the primary point of contact for cross-functional teams, including Marketing and Medical Affairs, to coordinate the MLR review workflow.

• Develops and maintains work instructions (WI) and Standard Operating Procedures (SOPs) to standardize the MLR process.

• Identifies opportunities for process improvement, works to streamline the MLR workflow, and resolves problems effectively.

• Skilled in using and overseeing the review of promotional and non-promotional materials through lifecycle management tools like Veeva PromoMats and MedComms.

• Ensures materials meet established review criteria prior to being circulated to reviewers through these tools.

• Oversees material reviews, tracks lifecycles, assists with regulatory submissions, and trains team members on processes and procedures.

• Demonstrates working knowledge of therapeutic areas, products, disease state information, and familiarity with trial designs, rationale, and data.

• Collaborates with Labeling/Regulatory to manage the workflow for label updates and ensures materials are updated appropriately, reviewed, and approved .

• Coordinate the development and distribution of MLR agendas, Prioritize, execute, and disseminate promotional/Non-promotional materials and facilitate the review process as well as setting up live meetings.

• Ensure all communications are properly vetted through the review process utilizing the online review system VeevaVault PromoMats, and Veeva MedComms.

• Capture and document consensus during live MLR meetings, Generate metrics from Veeva Vault on coverage, volume, and overall PRC performance, as needed.

• Ability to conduct system and process training for Internal and External parties new to the PRC/MRC process.

• Sound Knowledge of regulatory and legal compliance requirements (like FDA, EMA, Health Canada, MHRA etc), and managing HA Vetting/ OPDP 2253 submissions with the MLR Regulatory Reviewer/Partner is an added advantage.

• A minimum of 3+ years of relevant experience is mandatory.

• Excellent project management, oral and written communication skills is mandatory.