Sr. Manager, Medical Review - GCM
Bengaluru, Karnataka Job ID R0194431 Category Medical Affairs Subcategory Commercial Business Unit Global Portfolio Division Job Type Full timeBy 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:
• Provide Medical and scientific review expertise across MLR and cMLR processes, ensuring content is scientifically accurate, balanced, evidence-based, compliant, and aligned with approved data, product information, and scientific evidence in the literature.
• Serve as a key Medical reviewer and scientific advisor to content-development, Medical Communications, Congress, and Content Factory teams, enabling the development of high-quality, review-ready content and efficient approval pathways.
• Partner with Medical, Regulatory, Legal, Compliance, and cross-functional stakeholders to drive consistency, quality, and operational excellence across global content review and approval activities.
Key Responsibilities:
Medical & Scientific Review
• Conduct Medical and scientific review of promotional and non-promotional content, including Commercial, Medical Affairs, congress, digital, and field-facing materials, to ensure accuracy, balance, consistency, and alignment with approved data, product labeling, and scientific evidence in the literature.
• Evaluate scientific statements, references, data presentation, and clinical context for appropriateness and supportability.
• Provide clear, actionable, and scientifically grounded review feedback.
• Serve as the designated Medical reviewer within MLR and cMLR review processes for assigned therapeutic areas, brands, or content portfolios.
Content Factory Scientific Partnership
• Partner with Content Factory teams and stakeholders to provide scientific guidance throughout content planning, development, and review activities.
• Advise on evidence requirements, scientific statements (Medical) and claims (commercial) substantiation, scientific communication objectives, and communication of clinical data.
• Support development of reusable and globally scalable content by promoting consistency in scientific communication and evidence utilization, aligned with the approved Scientific Communication Platforms and Lexicons for related assets.
• Identify and proactively address scientific-review risks to enhance content quality and review readiness.
Cross-Functional MLR/cMLR Collaboration
• Participate in MLR/cMLR review discussions requiring scientific expertise and Medical judgment.
• Provide clear direction to project owners during the end-to-end lifecycle of the review, starting at the concept review stage until final approval for dissemination.
• Collaborate with Medical, Regulatory, Legal, Compliance, Commercial, Scientific Communications, and Content Operations stakeholders throughout the content-review lifecycle.
• Support resolution of scientific-review comments and content-related questions.
• Partner with MLR Operations teams to drive efficient and consistent review processes.
Scientific Excellence & Continuous Improvement
• Maintain current knowledge of assigned therapeutic areas, products, treatment guidelines, and emerging scientific evidence.
• Ensure Medical-review activities comply with applicable regulations, policies, and procedures.
• Contribute to Medical-review standards, best practices, guidance, and capability-building initiatives.
• Identify opportunities to improve content quality, review-cycle efficiency, and consistency across review activities.
Qualifications:
Experience: More than 7 years of relevant experience in the biopharmaceutical, healthcare, Medical Affairs, or Medical Communications industry, including at least 5 years supporting Medical review, MLR/cMLR, Medical Communications, or other regulated content-review activities. Experience collaborating with Medical, Regulatory, Legal, Compliance, and Commercial stakeholders; exposure to global or multi-market review environments and diverse content types is preferred.
Technical skills: Strong understanding of Medical review principles, MLR/cMLR processes, and regulated content-development practices.
• Ability to communicate complex scientific information clearly to both scientific and non-scientific audiences.
• Ability to critically evaluate clinical data, scientific literature, references, and evidence-based claims.
• Knowledge of pharmaceutical regulations, compliance requirements, publication standards, and scientific communications.
• Experience with Veeva Vault PromoMats, MedComms, iEnvision, or similar review platforms preferred.
• Strong communication, stakeholder management, collaboration, and influencing skills.
• Strong attention to detail with the ability to manage multiple concurrent review activities.
Education: Advanced degree in Medicine, Pharmacy, Life Sciences, Public Health, Medical Communications, or a related scientific discipline required; PharmD, MD, MBBS, PhD, or equivalent advanced scientific qualification strongly preferred.
Languages: Fluent English required; additional languages advantageous
