Decision Analytics Consultant - MLR Review (Medical, Legal ) ZS

7.0 - 10.0 years

9 - 12 Lacs

Pune, Bengaluru

Work from Office

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. What Youll Do 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. What Youll Bring 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.

Posted 3 days ago

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