Sr. Manager, Medical Review - GCM Bengaluru, Karnataka Category: Medical Affairs

Job description

Job Posting Find jobs for Location Radius Sr. Manager, Medical Review - GCM Bengaluru, Karnataka Apply Now Job ID R0194431 Category Medical Affairs Subcategory Commercial Business Unit Global Portfolio Division Job Type Full time 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 Apply Now Share this job • Facebook • Xing • LinkedIn • Email • Related content • Learn more • Frequently Asked Questions Learn more • Healthcare for all Learn more • How We Partner Learn more • Innovators in Science Award Winners Learn more • • Luck is not a strategy Learn more • Takeda Unveils Newly Renovated Cambridge Building Learn more • Our Commitment to the Planet Learn more • Our Products Learn more • Our R&D Pipeline Learn more • • Patient Story: Rosie Learn more • Putting Patients First Learn more • Sustainable Value Report 2023 Learn more • Takeda Global Headquarters Learn more • Informiere dich über Stellenangebote Takedas Produktionsstandort Learn more • • • • Takeda in the US Learn more • Takeda’s Global CSR Program Learn more • The History of Takeda Learn more • Values and Corporate Governance Learn more • Takeda Manufacturing - 2021 Facilities of the Year Learn more • • Takeda Acquires Adaptate Therapeutics Learn more • • BioLife Plasma Services Learn more • • Biotech Site in Covington, GA Learn more <li class="js-hub-item hub-content__item showing-by-filter showing-by-load" data-hub-read-time="" data-hub-origin="False" data-hub-title="Takeda’s Position on Climate Change" data-hub-meta-title="" data-hub-meta="" data-hub-url="jobs.takeda.com/" data-hub-isfallbackpage="False" data-hub-order="0" data-hub-link="https://www.takeda.com/4ab3a2/siteassets/system/who-we-are/companyinformation/positions--guidelines/takeda_position_climate_change_2020.pdf" data-hub-image="https://tbcdn.talentbrew.com/company/1113/v3_0/img/content/rc_climate_change.png" data-hub-created-by="TMP created" data-hub-date-updated="02/26/2025 19:36:54" data-hub-date-created="02/26/2025 19:36:54" data-hub-date-override="08/14/2