MLR Activity Manager

Takeda; Bengaluru; Hybrid; INR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Hybrid work environment

Healthcare and life insurance

Learning platforms

Employee Assistance Program

Leave for voluntary service

Diversity & Inclusion programs

Job summary

Takeda in Bengaluru, India seeks an experienced MLR/CMLR Coordination professional to manage intake, submission, reviewer coordination and tracking of content for regulated and commercial use.

Role requires 3+ years in biopharma, with strong familiarity with MLR/CMLR processes, document control and version tracking. Hybrid work arrangement offered with comprehensive benefits.

Qualifications

• More than 3 years in related roles; 5+ years in biopharmaceutical industry preferred.
• Experience in Medical-review operations, Scientific Communications or document control.
• Regulatory/compliance awareness desirable.

Responsibilities

• Coordinate intake, readiness checks, submission, reviewer coordination and approval tracking.
• Track comments, revisions, resubmissions and final disposition through workflows.
• Maintain controlled records for internal reuse and release status.
• Monitor cycle time, backlog and ensure on-time delivery; escalate issues as needed.

Skills

MLR workflows

CMLR workflows

Veeva Vault

Review coordination

Version tracking

Attention to detail

Education

Life sciences/Regulatory degree

Tools

Veeva Vault

PromoMats

MedComms tools

Job description

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