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Takeda

Sr. Manager, Medical Review - GCM

  • IND - Bengaluru
  • Full-time
  • Posted

Skills

  • Communication
  • Compliance
  • Teamwork

Job description

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 :

•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

Locations

IND - Bengaluru

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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