Evidence Generation Evidence Records & Reuse Lead
BengaluruFull-time3–6 yrsPosted over a month ago
Mid-level legal role at IND - 2025 Takeda Biopharmaceuticals in Bengaluru. Needs 3+ years.
About the role
Execute evidence-record centralization, maintenance and reuse-assessment activities within the Bengaluru GCM, ensuring records are complete, traceable and linked to approved evidence decisions Support other Strategy Leads in PRO/COA benchmarking, IEP coordination, and scenario planning in support of R&D, access, pricing, and commercial launch strategy decisions
What you'll do
- Check record completeness against evidence repository requirements before upload
- Upload evidence records to the designated central repository, applying naming conventions, tagging, access controls, and retention category assignments
- Maintain evidence logs and version histories to support audit traceability and governance requirements; own ongoing repository hygiene including metadata integrity
- Conduct structured searches across evidence repositories, prior studies, regulatory submissions, and existing evidence packages to identify potentially reusable evidence
- Prepare reuse summary documents with source links, assumptions, and fit-for-purpose notes for review and final strategic decision by Global Evidence Generation
What you need
- Regulatory affairs
- Documentation