Associate Director, MLR Lead

Takeda Pharmaceutical Co.; Bengaluru; Hybrid; INR 1,800,000 - 2,400,000; Full time

Benefits offered by this job

Hybrid work environment

Health and life insurance

Learning and development programs

Employee assistance program

Premium healthcare plans

Job summary

Takeda in Bengaluru seeks a seasoned Medical Review & Quality Leader to oversee c/MLR workflows for medical and commercial content, ensure QC of Content Factory outputs and manage end-to-end review processes. You will drive governance, accuracy, and traceability across multiple workflows while coordinating cross-functional teams.

Ideal candidates have 10+ years in biopharma operations with strong leadership skills, experience in medical writing/affairs operations, and a track record of

Qualifications

• Over 10 years of related experience in biopharmaceutical operations or medical review
• Experience leading teams or senior individual contributors
• Strong knowledge of MLR/CMLR workflows and scientific QC

Responsibilities

• Lead c/MLR Activities and Quality Control teams and coordinate handoffs to governance
• Oversee intake, prioritization, capacity, backlog and delivery against timelines
• Define and maintain SOPs, QC checklists and escalation pathways
• Monitor review cycle time and quality metrics and drive continuous improvements
• Escalate critical scientific or compliance decisions to accountable owners

Skills

Leadership

Stakeholder coordination

Quality governance

Capacity management

Data-driven decisions

Education

Life sciences 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

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

• 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

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer.