MLR Activity Manager
Full Job Posting
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
Qualifications
- 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
Preferred Qualifications
- 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
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
About Takeda
Takeda is a global research-driven biopharmaceutical company headquartered in Japan. It develops and delivers treatments across gastrointestinal and inflammatory diseases, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines.
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