Decision Analytics Consultant - MLR Review (Medical, Legal )

Decision Analytics Consultant - MLR Review (Medical, Legal, and Regulatory)

The Consultant for MLR Review in the DCE Marketing Services team is a critical member responsible for overseeing the review and approval of promotional and non-promotional materials. This role demands expertise in the end-to-end Medical, Legal, and Regulatory (MLR) review and submission processes, ensuring compliance with external regulations, industry standards (EFPIA/IFPMA), and company policies. The Consultant collaborates with cross-functional teams to provide regulatory guidance and streamline operations across the MLR landscape.

WhatYoullDo

• Compliance Advisory:

  Serve as the lead compliance advisor for designated therapy areas, ensuring all promotional and non-promotional content complies with global standards, including disease awareness and scientific communications.

• MLR Review Oversight:

  Manage the full MLR (Medical, Legal, Regulatory) review cycle, guaranteeing timely, accurate submissions and approvals in line with regulatory requirements.

• Expert Guidance:

  Provide subject matter expertise across MLR processes, including documentation, workflow systems, and cross-functional collaboration.

• Strategic Input:

  Offer compliance-focused strategic input during concept reviews to align content development with both business objectives and regulatory standards.

• Training & Enablement:

  Lead training initiatives on MLR systems and compliance for internal stakeholders across functions such as sales, marketing, and medical affairs.

• Global Collaboration:

  Work closely with country affiliates to support material approvals, resolve compliance issues, and share best practices across regions.

• Labeling Compliance:

  Keep stakeholders updated on EU labeling changes and assess their impact on promotional and non-promotional material content.

WhatYoullBring

• 7-10 years of experience in regulatory, medical affairs, or healthcare compliance, with a strong focus on MLR review processes.
• Expertise in global standards for advertising and promotion, including EFPIA/IFPMA codes and ABPI Code of Practice.
• Familiarity with regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA) and their compliance expectations.
• Thorough understanding of the MLR review and submission process, including workflows, approvals, and stakeholder management.
• Ability to effectively communicate regulatory requirements and provide strategic guidance to cross-functional teams.
• Strong organizational skills with the ability to manage multiple priorities and meet deadlines in a fast-paced environment.
• This Consultant role offers a dynamic opportunity to ensure compliant and efficient MLR operations while supporting strategic business objectives across the pharmaceutical marketing landscape.