Evidence Generation Enablement & Planning Lead: PRO/COA Implementation & Benchmarking

Overview

Support PRO/COA strategy development and implementation through structured benchmarking, landscape scans, evidence pulls, precedent tracking, and documentation support for Global Evidence Generation SMEs.

What you'll do

• 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 meaningful established clinical thresholds exist.
• Flag gaps, limitations, market-specific considerations, and precedent constraints for Global Evidence Generation review.
• Maintain PRO/COA benchmark trackers, source libraries, evidence summaries, and supporting documentation by asset, indication, and/or disease area.
• Store source materials, strategy notes, benchmark outputs, decision rationale, and supporting references in the designated repository, applying 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.
• 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.
• Use approved digital, analytical, automation, and AI-enabled tools for evidence retrieval, sensitivity analysis, assumption documentation, and first-pass summaries, with human review of all outputs for accuracy, traceability, privacy, scientific integrity, and compliance.
• Use approved repositories, collaboration tools, and project-management platforms to maintain current, version-controlled, decision-ready materials.

What you'll need

• More than 2 years of related work experience.
• More than 2 years of experience in the biopharmaceutical industry.
• 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 documentation.
• Strong Excel and project management software skills.
• Familiarity with AI tools for landscape scans and benchmarking.
• Strong documentation, version-control, repository management, and attention-to-detail skills.
• Ability to distinguish operational benchmarking support for US scientific interpretation and strategy decisions.
• A degree in a scientific, medical, life sciences, pharmacy, public health, outcomes research, epidemiology, or health economics.
• Fluent English.

Nice to have

• Experience in HEOR, PRO/COA support, market-access evidence, RWE Operations, Medical Affairs Operations, or scientific project coordination.
• Familiarity with regulatory reviews, HTA submissions, payer evidence requirements, publication databases, evidence repositories, and study documentation.
• Additional languages.

Details

• Location: IND - Bengaluru.
• Employment type: Full time, Regular employee.
• Flexible work environment, including hybrid working.