Evidence Generation Enablement & Planning Lead: PRO/COA Implementation & Benchmarking
PharmaRegulatory Affairsheormedicalhtacroinform
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 About the Role Support PRO/COA strategy development through structured benchmarking, landscape scans, evidence pulls, precedent tracking, and documentation support. Provide consistent, traceable, and high-quality benchmarking execution and delivery to support and enable Global Evidence Generation SMEs to focus on strategy, endpoint selection, scientific interpretation, and final decisions. Support implementation of COA strategy. How You Will Contribute PRO/COA Benchmarking Support ·Conduct PRO and COA benchmark scans across comparator assets, precedent studies, HTA examples, payer requirements, regulatory examples, and published evidence Summarize relevant PRO instruments, COA endpoints, endpoint-use patterns, market-specific requirements, and evidence expectations Identify comparator precedents, study design examples, endpoint definitions, timing of assessment, and evidence-use context where there are meaningful established clinical thresholds Flag gaps, limitations, market-specific considerations, and precedent constraints for Global Evidence Generation review Evidence Pulls, Trackers & Repository Management Maintain PRO/COA benchmark trackers, source libraries, evidence summaries, and supporting documentation by asset, indication, and/or disease area as appropriate Store source materials, strategy notes, benchmark outputs, decision rationale, and supporting references in the designated repository Apply required naming conventions, metadata, version control, access rules, and study asset linkage Update benchmark libraries as new evidence, regulatory/labeling, HTA feedback, payer requirements, or study precedents become available Stakeholder Coordination & Escalation Coordinate inputs from Global Evidence Generation, HEOR, Market Access, R&D, LOCs, and PRO/COA SMEs to clarify benchmark questions, asset scope, indication, geography, and intended decision use Prepare concise benchmark outputs for US review, including source links, assumptions, limitations, and open questions Escalate endpoint selection questions, market applicability issues, strategic implications, and scientific interpretation needs to Global Evidence Generation or PRO/COA owners Support continuous improvement of PRO benchmarking templates, trackers, and source library structure Digital, Automation, and AI-Enabled Ways of Working Use approved digital, analytical, automation, and AI-enabled tools to support evidence retrieval, scenario execution, sensitivity analysis, assumption documentation, and first-pass summaries where appropriate. Apply human review to technology-supported outputs to confirm accuracy, completeness, source traceability, privacy, scientific integrity, quality, and compliance. · Use approved repositories, collaboration tools, and project-management platforms to maintain current, version-controlled, and decision-ready scenario materials. Skills and Qualifications Experience More than 2 years of related work experience and more than 2 years of experience in the biopharmaceutical industry. Experience in HEOR, PRO/COA support, market-access evidence, RWE Operations, Medical Affairs Operations, or scientific project coordination preferred . Technical and Functional Skills Working knowledge of PRO/COA concepts, endpoint benchmarking, regulatory or health authority requirements/guidance, HTA evidence expectations, and evidence generation planning Ability to conduct structured evidence pulls, benchmark scans, source summaries, and gap documentations Familiarity with regulatory reviews, HTA submissions, payer evidence requirements, publication databases, evidence repositories, and study documentation preferred Strong Excel and project management software skills Familiarity with AI tools for landscape scans, benchmarking, etc. Strong documentation, version-control, repository management, and attention-to-detail skills ·Ability to distinguish operational benchmarking support for US scientific interpretation and strategy decisions Education and Languages ·A degree in a scientific, medical, life sciences, pharmacy, public health, outcomes research, epidemiology, or health economics is required. Fluent English is required; additional languages are advantageous. Benefits It is our priority to provide competitive compensation and a benefit package that bridges your personal life with your professional career. Amongst our benefits are: Competitive Salary + Performance Annual Bonus Flexible work environment, including hybrid working Comprehensive Healthcare Insurance Plans for self, spouse, and children Group Term Life Insurance and Group Accident Insurance programs Health & Wellness programs including annual health screening, weekly health sessions for employees. Employee Assistance Program 5 days of leave every year for Voluntary Service in addition to Humanitarian Leaves Broad Variety of learning platforms Diversity, Equity, and Inclusion Programs No Meeting Days Reimbursements – Home Internet & Mobile Phone Employee Referral Program Leaves – Paternity Leave (4 Weeks) , Maternity Leave (up to 26 weeks), Bereavement Leave (5 days) About ICC in Takeda Takeda is leading a digital revolution. We’re not just transforming our company; we’re improving the lives of millions of patients who rely on our medicines every day. As an organization, we are committed to our cloud-driven business transformation and believe the ICCs are the catalysts of change for our global organization. Locations IND - Bengaluru Worker Type Employee Wor
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