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

About Us

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.

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