Remote Senior Epidemiology Leader for PMR/PMC

Jazz Pharmaceuticals; California (MO); Remote; USD 120,000 - 180,000; Full time

Job summary

Jazz Pharmaceuticals seeks a Senior Manager of Epidemiology to lead non-interventional pharmacoepidemiology studies and to support PMR/PMC regulatory commitments across US and EU. You will identify data sources for regulatory submissions and contribute to RMPs, PBRERs and other documents for investigational medicines.

You will develop statistical analysis plans, manage CROs and external investigators, and collaborate with Clinical Development, Medical Affairs, Biostatistics and Regulatory to

Qualifications

• Advanced degree in epidemiology or related field.
• Minimum 2 years in pharma, CRO, or academia.
• Experience with rare disease studies.
• Ability to manage multiple studies and projects.
• Excellent English communication skills.
• Willingness to travel ~10%.

Responsibilities

• Conduct literature searches to identify epidemiology data across geographies.
• Support regulatory submissions (RMPs, safety queries, orphan designations).
• Provide data for forecasting and regulatory deliverables.
• Identify US/EU secondary data sources (claims, EMR).
• Lead RFPs for CROs and data providers for studies.
• Manage external teams to deliver on PMR/PMC timetables.
• Coordinate with Regulatory Leads on submission status.
• Collaborate with Clinical Development, Medical Affairs, Biostatistics.

Skills

Epidemiology

Biostatistics

Regulatory submissions

Project management

Vendor management

Communication skills

Remote work

SAS

R

EMR/claims data

Education

MS/MPH/MSPH/PhD in epidemiology

Tools

SEER*Stat

SAS

R

Job description

Jazz Pharmaceuticals seeks a Senior Manager of Epidemiology to lead non-interventional pharmacoepidemiology studies and to support PMR/PMC regulatory commitments across US and EU. You will identify data sources for regulatory submissions and contribute to RMPs, PBRERs and other documents for investigational medicines.

You will develop statistical analysis plans, manage CROs and external investigators, and collaborate with Clinical Development, Medical Affairs, Biostatistics and Regulatory to