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Job Description

About the Role:

Support study concept development, including data and evidence source landscaping, study synopsis drafting support, protocol drafting support, review coordination, scenario planning, comment collation, version tracking, and final review package preparation.
Provide structured drafting, documentation, and coordination support to enable Global Evidence Generation to define evidence questions, study concepts, scientific design, methodology strategy, source selection, and final sign-offs.

How You Will Contribute
Evidence Source Landscaping
• Conduct source landscaping across real-world data, registries, claims, electronic health records, clinical trials, literature, primary data collection,



and other available evidence sources.
• Summarize source coverage, strengths, limitations, access constraints, quality considerations, and selection tradeoffs.
• Prepare source-landscape outputs and store source summaries and decision rationale in the appropriate repository.
• Synopsis and Protocol Support
• Draft synopsis shells, first-pass synopsis content, simpler or standardized protocol sections, and supporting materials using approved templates and approved AI support where applicable.
• Review and manually refine AI-supported or first-pass content for clarity, completeness, formatting, and alignment with study intent.
• Update synopsis and protocol versions, track changes, collate comments, and prepare final review packages.
• Route final approved materials and maintain review history, comments, decisions, and supporting evidence.
• Cross-Functional Review Coordination
• Gather input from required s

📌 Manager, Evidence Generation Study Design (Bengaluru)
🏢 Takeda
📍 Bengaluru