Role at a glance
- Salary
- Not Disclosed
- Location
- IND, Bengaluru
- Employment
- Full-time
- Experience
- More than 3 years of related experience; more than 5 years in the biopharmaceutical industry
- Education
- A Medical, scientific, pharmacy, life sciences, regulatory, Medical communications or related degree is required
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Role Summary
This role coordinates MLR workflows for medical content and CMLR workflows for commercial content, from intake and reviewer coordination through approval and release tracking. It also covers tracking and controlled reuse of approved content, based in Bengaluru, India, as a full-time position.
What You'll Do
- Receive and validate review requests and supporting documentation, and run readiness checks before routing content through MLR or CMLR...
- Initiate and maintain submissions in Veeva Vault or applicable review platforms, coordinating reviewer access, timelines, and reminders.
- Consolidate reviewer feedback, identify conflicting or incomplete comments, and coordinate agreed revisions with content owners.
- Receive and validate internal-reuse requests and link reused assets to the approved source, review history, and release record.
- Monitor review cycle time, backlog, on-time delivery, rework, and overdue actions.
- Escalate incomplete submissions and questions requiring scientific, legal, regulatory, compliance, or policy judgment.
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
A medical, scientific, life sciences, regulatory, or related degree with more than 3 years of related experience, working knowledge of MLR/CMLR workflows, and fluent English.
Required
- A Medical, scientific, pharmacy, life sciences, regulatory, Medical communications or related degree
- More than 3 years of related experience
- More than 5 years in the biopharmaceutical industry
- 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
Preferred
- Experience in Medical-review operations, Scientific Communications, Medical-content operations, commercial-content review coordination...
- Additional languages
Original job description
Content provided by the employer
Original job description
Content provided by the employer
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 - BengaluruWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeAbout the company
Takeda
Large Enterprise
Takeda is a global biopharmaceutical company headquartered in Tokyo, Japan, with a rich history spanning over 240 years. Specializing in the research, development, and commercialization of innovative medicines, Takeda focuses on therapeutic areas such as oncology, gastroenterology, neuroscience, and rare diseases. Committed to improving patient outcomes, the company harnesses advanced technologies and scientific expertise to deliver breakthrough therapies and enhance healthcare worldwide. Takeda's dedication to sustainability and social responsibility underscores its mission to strive towards better health for people and communities across the globe.