Associate Director, MLR Lead

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Job Description Role Objectives:

• Lead the Bengaluru GCM Medical-review operations capability across c/MLR Activities and Quality Control, covering MLR for medical content, CMLR for commercial content, review coordination, comment consolidation, resubmission, approval-status tracking and compliant-reuse tracking
• Ensure materials are complete, traceable and operationally ready for formal review while accountable Medical, Legal and Regulatory reviewers retain scientific interpretation and final approval
• Own capability capacity, delivery performance, quality governance and escalation Key Responsibilities : Medical Review & Quality Leadership
• Oversee c/MLR operational workflows for medical and commercial content, including intake, pre-checks, submissions, reviewer coordination, comment consolidation, revisions, resubmissions, approval-status tracking and compliant-reuse tracking
• Oversee first-pass Quality Control of Content Factory outputs, including reference anchoring, claim support, tagging, metadata, templates, source traceability and completeness
• Ensure completed review records and supporting evidence are handed off to the GCM Medical Governance Lead responsible for Approval Documentation & Audit through the defined controlled workflow
• Ensure review status, comments, versions, decisions and release conditions remain controlled and traceable across c/MLR and internal-reuse workflows Team & Delivery Leadership
• Lead the c/MLR Activities and Quality Control teams and coordinate completed-review handoffs to the Medical Excellence Approval Documentation & Audit role
• Manage intake, prioritization, capacity, backlog and overnight handoffs against agreed timelines and expectations
• Coordinate with the GCM Content Factory Integration Leads to manage review-ready intake, corrections, rework and routing to accountable reviewers Governance, Performance & Improvement
• Define and maintain operational SOPs, QC checklists, escalation pathways and review-workflow controls with Global Medical and cross-functional stakeholders
• Monitor first-pass quality, review cycle time, backlog, rework, on-time delivery and recurring quality issues
• Escalate scientific interpretation, claim-boundary, compliance or approval decisions to the accountable Medical, Legal or Regulatory owner
• Drive improvements to templates, workflows, training, automation and performance reporting based on quality and delivery trends Qualifications : Experience: More than 10 years of related experience; more than 7 years in the biopharmaceutical industry; at least 5 years in scientific communications, Medical review, Medical writing or Medical Affairs Operations; experience leading teams or senior individual contributors preferred Technical skills:
• Strong knowledge of MLR/CMLR workflows, scientific QC, reference anchoring, claim support, & Veeva Vault
• Working knowledge of approval-documentation, audit-readiness and version-control requirements, with experience coordinating controlled handoffs to governance teams
• Strong people leadership, capacity management, and stakeholder coordination
• Ability to use performance data to improve quality, cycle time and review readiness Education: Medical, scientific, pharmacy, life sciences or related degree required; advanced degree preferred Languages: Fluent English required; additional languages advantageous BENEFITS: It is our priority to provide competitive compensation and a benefit package that bridges your personal life with your professional career. Amongst our benefits are: Competitive Salary + Performance Annual Bonus Flexible work environment, including hybrid working Comprehensive Healthcare Insurance Plans for self, spouse, and children Group Term Life Insurance and Group Accident Insurance programs Health & Wellness programs including annual health screening, weekly health sessions for employees. Employee Assistance Program 5 days of leave every year for Voluntary Service in additional to Humanitarian Leaves Broad Variety of learning platforms Diversity, Equity, and Inclusion Programs Reimbursements – Home Internet & Mobile Phone Employee Referral Program Leaves – Paternity Leave (4 Weeks), Maternity Leave (up to 26 weeks), Bereavement Leave (5 days) Locations IND
• Bengaluru Worker Type Employee Worker Sub-Type Regular Time Type Full time