Remote Senior Epidemiology Manager, Regulatory Submissions

BioSpace; Carlsbad (CA); Remote; USD 142,000 - 212,000; Full time

Job summary

Jazz Pharmaceuticals is a global biopharma company focused on transforming patient lives through innovative medicines. A Senior Manager of Epidemiology will provide scientific leadership and operational oversight for non-interventional studies, supporting PMR/PMC commitments and regulatory submissions.

The role involves identifying epidemiology data, coordinating with US/EU teams, and leading external vendors to deliver timely, high-quality results, with remote work capability and ~10% travel.

Qualifications

• Advanced degree in epidemiology or a related discipline (health services research, outcomes research, public health, pharmaceutical sciences).

Responsibilities

• Conduct/outsource literature searches to identify epidemiology data across geographies.
• Contribute epidemiology data to regulatory submissions and PMR/PMC related documents.
• Provide data for forecasting and commercial planning.
• Identify US/EU secondary data sources (claims, EMR).
• Lead RFPs/SoWs for CROs and data providers for studies.
• Support Phase IV non-interventional study team for regulatory submissions.
• Develop statistical analysis plans with biostatistician.
• Oversee CROs/Data Providers to deliver high-quality results on time.
• Communicate plans, timelines, budgets, and results to internal Jazz teams.
• Collaborate with Clinical Development, Medical Affairs, Biostatistics, Regulatory Affairs.
• Present findings at scientific venues and co-author publications.

Skills

Epidemiology

Biostatistics

Communication

Project management

MS Office (Word/Excel/PowerPoint)

Remote work capability

Cross-functional coordination

Education

Advanced degree in epidemiology or related field (MS/MPH/MSPH/PhD)

Oncology therapeutic area experience (preferred)

Tools

SAS

Stata

R

SEER*Stat

Job description

Jazz Pharmaceuticals is a global biopharma company focused on transforming patient lives through innovative medicines. A Senior Manager of Epidemiology will provide scientific leadership and operational oversight for non-interventional studies, supporting PMR/PMC commitments and regulatory submissions.

The role involves identifying epidemiology data, coordinating with US/EU teams, and leading external vendors to deliver timely, high-quality results, with remote work capability and ~10% travel.