Global HEOR Quality Lead & Advisor

BioSpace; Indianapolis (IN); Sur place; USD 66 000 - 172 000; Plein temps

Avantages offerts par ce poste

401(k) plan

Pension

Vacation benefits

Medical insurance

Dental insurance

Vision benefits

Well-being programs

Résumé du poste

Lilly is seeking a HEOR-quality partner to lead quality direction for health economics and outcomes research, with a focus on real world data and regulatory standards. You will drive CAPA, risk assessments, and cross‑functional collaboration across Clinical Development, Regulatory Affairs, and Pharmacovigilance.

The role centers on ensuring inspection readiness, coordinating responses to regulatory inquiries, and delivering robust quality improvements across HEOR programs globally.

Qualifications

• Bachelor’s Degree in 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.

Responsabilités

• Interprets regulations and defines quality direction for HEOR and related studies.
• Leads inspection readiness and manages regulatory inspections and responses.
• Partners across Clinical Development, Pharmacovigilance, and Regulatory Affairs to ensure HEOR quality.
• Drives CAPA processes, risk assessment, and continuous improvement.

Connaissances

Quality management

HEOR

Real world evidence

Epidemiology

Project management

Formation

Bachelor’s Degree in science/tech/medical field

Description du poste

Lilly is seeking a HEOR-quality partner to lead quality direction for health economics and outcomes research, with a focus on real world data and regulatory standards. You will drive CAPA, risk assessments, and cross‑functional collaboration across Clinical Development, Regulatory Affairs, and Pharmacovigilance.

The role centers on ensuring inspection readiness, coordinating responses to regulatory inquiries, and delivering robust quality improvements across HEOR programs globally.