MLR Activity Manager

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: •       Coordinate MLR workflows for Medical content and CMLR workflows for commercial content, including intake, readiness checks, submission, reviewer coordination, comment consolidation, revisions, resubmission and approval-status tracking •       Coordinate review and tracking for approved content intended for compliant internal reuse, maintaining a controlled and traceable record of requests, comments, versions, decisions and release status Key Responsibilities: c/MLR Intake & Submission Coordination •       Receive and validate review requests, intended use, audience, source asset, required reviewers, references and supporting documentation •       Conduct operational completeness and readiness checks and route Medical content through MLR processes and commercial content through CMLR processes •       Initiate and maintain submissions in Veeva Vault or applicable review platforms; coordinate reviewer access, timelines, reminders and required inputs Review Coordination & Comment Consolidation •       Track reviewer comments, decisions, actions, revisions, resubmissions and final disposition through workflow completion •       Consolidate feedback, identify conflicting or incomplete comments and route questions to accountable owners for resolution •       Coordinate agreed revisions with content owners and confirm final materials reflect approved decisions Reuse, Version & Release Tracking •       Receive and validate internal-reuse requests, including intended audience, market, use case and proposed modifications •       Link reused assets to the approved source, review history, usage conditions and final release record •       Maintain the controlled single source of truth for status, versions, approvals, due dates, decisions and release conditions Performance & Improvement •       Monitor review cycle time, backlog, on-time delivery, rework, overdue actions, reuse volumes and recurring workflow issues •       Escalate incomplete submissions, disputed feedback, delays and questions requiring scientific, legal, regulatory, compliance or policy judgment •       Apply approved SOPs, checklists and escalation pathways and support improvements to intake, templates, training, tracking and automation Qualifications: Experience: More than 3 years of related experience; more than 5 years in the biopharmaceutical industry; experience in Medical-review operations, Scientific Communications, Medical-content operations, commercial-content review coordination or document control preferred Technical skills: •       Working knowledge of MLR and CMLR workflows and regulated content-review processes •       Experience with Veeva Vault, PromoMats, MedComms or equivalent review platforms •       Review coordination, status tracking, version control and documentation capabilities •       Familiar with Medical  & commercial content-review pathways, internal reuse and approval boundaries •       High attention to detail and ability to manage multiple concurrent reviews Education: A Medical, scientific, pharmacy, life sciences, regulatory, Medical communications or related degree is required 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