Associate Director, MLR Lead

Takeda; Bengaluru; Hybrid; INR 2,600,000 - 4,800,000; Full time

Benefits offered by this job

Hybrid work environment

Healthcare insurance

Life insurance

Annual bonus

Job summary

Takeda in Bengaluru seeks a senior leader to manage Medical Review and Quality Control operations. You will coordinate c/MLR, CMLR, and governance workflows, ensuring timely reviews, traceability, and compliance. You will also lead the team, manage capacity, and drive improvements with cross-functional stakeholders.

The role requires 10+ years in biopharma, strong project leadership, and fluency in English. Hybrid work and comprehensive benefits are offered.

Qualifications

• Experience in medical review, medical writing, or medical affairs operations.
• Experience leading teams or senior individual contributors.
• Ability to coordinate reviewed content and governance.

Responsibilities

• Lead c/MLR Activities and Quality Control teams.
• Oversee workflows for intake, pre-checks, submissions, coordination and archiving.
• Define SOPs, QC checklists, escalation paths, and performance reporting.

Skills

MLR/CMLR workflows

Quality Control

People leadership

Capacity management

Performance data analysis

Education

Medical/science/pharmacy degree

Advanced degree preferred

Tools

Veeva Vault

Job description

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

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