Associate Director, MLR Lead
Bengaluru, Karnataka Job ID R0191769 Category Medical Affairs Subcategory Commercial Business Unit Global Portfolio Division Job Type Full timeBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
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)
