Associate Director, MLR Lead

By 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) Locations IND - Bengaluru Worker Type Employee Worker Sub-Type Regular Time Type Full time