Senior HEOR Quality Strategist & Global Compliance Advisor

Eli Lilly and Company; Indianapolis (IN); In loco; USD 120.000 - 170.000; Tempo pieno

Vantaggi offerti da questo lavoro

401(k)

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Life insurance

Descrizione del lavoro

Lilly in Indianapolis, IN seeks a HEOR quality partner to oversee non‑interventional studies, real world data tools, and data synthesis for external disclosure.

You will interpret regulations, lead CAPA and risk assessments, and ensure GxP, HTA, and privacy compliance while collaborating with Clinical Development, Global Regulatory Affairs, and IT.

The role emphasizes inspection readiness, audit responses, harmonization of practices, and influencing quality direction across regions.

Competenze

• Bachelor’s Degree in a science, technology or medically related field or equivalent relevant work experience.
• At least 5 years’ experience in quality, health economics and outcomes research, real world evidence, epidemiology, or a related pharmaceutical research discipline.
• Extensive knowledge of GxP regulations, guidelines, and standards.
• Project management experience.

Mansioni

• Interprets regulations and guidelines, defines quality direction, and provides input into quality systems for HEOR and RWE.
• Leads inspection readiness and supports regulatory inspections and assessments.
• Partners across Clinical Development, Pharmacovigilance, Regulatory Affairs, Medical Affairs, and IT to ensure quality.
• Manages CAPA, deviations, change management, root cause investigation, and corrective actions.
• Drives harmonization of best practices across regions and cross‑functional teams.

Conoscenze

Quality assurance

HEOR knowledge

GxP knowledge

English proficiency

Formazione

Bachelor’s degree in science/tech/med field

Descrizione del lavoro

Lilly in Indianapolis, IN seeks a HEOR quality partner to oversee non‑interventional studies, real world data tools, and data synthesis for external disclosure.

You will interpret regulations, lead CAPA and risk assessments, and ensure GxP, HTA, and privacy compliance while collaborating with Clinical Development, Global Regulatory Affairs, and IT.

The role emphasizes inspection readiness, audit responses, harmonization of practices, and influencing quality direction across regions.