Medical, Legal and Regulatory; MLR) Coordinator

• Full-time
• Department:
  Clinical & Medical
• Job Family:
  Medical Writing

At EVERSANA®, we are proud to be a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 6,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 670 clients ranging from innovative biotech start-ups to established pharmaceutical companies.

Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us!

Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs.

We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA.

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 Promo Mats and Vault Med Comms)
• 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 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…