Sr. Principal, Advisor, Sr. Advisor - Global Medicines Quality Organization

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

This role is the primary quality partner for Health Economics and Outcomes Research (HEOR) - covering observational and non-interventional studies, real world data (RWD) tools and platforms, health economic modeling, literature review, and meta-analysis and data synthesis for external disclosure.

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* Primary Responsibilities:

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* Functional and Technical Expertise

+ Interprets regulations and guidelines, defines quality direction, and provides direct input into quality systems to meet internal and external expectations. For HEOR this includes the non-interventional and real world evidence (RWE) framework:
Good Pharmacovigilance Practices (GVP) Module VIII (Post-Authorisation Safety Studies), European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) standards, European Union Post-Authorisation Study (EU PAS) Register expectations, United States Food and Drug Administration (FDA) real world evidence guidance, Health Technology Assessment (HTA) methodological requirements, and data privacy regulation governing secondary use of patient data.

+ Applies quality expectations specific to RWE methodology - pre-specification of analyses, protocol approval and registration prior to conduct, fit-for-purpose assessment of data sources, traceability of key study decisions, and independent quality review of deliverables.

+ Performs ongoing risk assessment to identify performance and compliance gaps against current regulations, company standards, and internal procedures, and recommends robust corrective actions.

+ Analyzes data proactively to identify emerging issues, trends, and improvement opportunities.

+ Expert in corrective and preventive action (CAPA) management; ensures deviations, change management, root cause investigation, and corrective/preventive actions are managed, documented, escalated, and completed.

+ Reports issues through Notification to Management (NTM) as appropriate.

+ Provides input into Global Quality Auditing (GQA) audit plans based on identified signals, risks, and gaps.

+ Defines, executes, and documents quality self-assessments and self-inspections, and discusses output with business partners.

+ Serves as Business Quality Assurance (BQA) - performing Information Technology (IT) Business Quality responsibilities as defined in Computer System Policies and Procedures, reviewing and approving system development and maintenance documentation, and partnering with IT and the business on system related initiatives and changes.

+ Provides quality consultation for HEOR, interacting at all levels across Clinical Development, Global Patient Safety, Global Regulatory Affairs, Medical Affairs, Market Access, Legal, Privacy, and Information Technology.

Inspection Readiness and Inspection Management

+ Leads pre-inspection preparation and educates internal and external business partners on inspection management and expectations.

+ Supports regulatory inspections and assessments, including backroom and front room support. HEOR activities are most commonly examined through pharmacovigilance inspections and through health authority and HTA…