Associate Director, MLR Lead
Takeda · IND - Bengaluru, India
Free account: apply link, HR contact and an AI-written cold email
Takeda · IND - Bengaluru, India
Free account: apply link, HR contact and an AI-written cold email
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:
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