Senior Manager, Epidemiology

Jazz Pharmaceuticals; Carlsbad (CA); On-site; USD 160,000 - 230,000; Full time

Job summary

Jazz Pharmaceuticals seeks a Senior Manager of Epidemiology to lead non-interventional pharmacoepidemiology studies and manage PMR/PMC commitments for regulatory authorities. The role includes identifying relevant epidemiology data for regulatory submissions and supporting RMPs, PBRERs, and orphan designation processes within Jazz's R&D portfolio.

The Senior Manager will report to the Senior Director of Epidemiology and will coordinate with global teams to ensure high-quality, scientifically

Qualifications

• Experience leading non-interventional pharmacoepidemiology studies.
• Ability to support PMR/PMC regulatory commitments.
• Experience identifying epidemiology data for regulatory submissions.

Responsibilities

• Conduct/outsource literature searches

Skills

Epidemiology

Post-marketing surveillance

Regulatory submissions

PBRERs

RMPs

Tools

Literature databases

Job description

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to
transform the lives of patients and their families. We are dedicated to developing
life-changing medicines for people with serious diseases - often with limited or no
therapeutic options. We have a diverse portfolio of marketed medicines, including leading
therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.
Our patient-focused and science-driven approach powers pioneering research and development
advancements across our robust pipeline of innovative therapeutics in oncology and
neuroscience. Jazz is headquartered in Dublin, Ireland with research and development
laboratories, manufacturing facilities and employees in multiple countries committed to
serving patients worldwide. Please visit
www.jazzpharmaceuticals.com
for more information.

Brief Description:

A Senior Manager (SM) of Epidemiology will support the epidemiological activities of Jazz' Global Research & Development (R&D) organization. This role will be responsible for the scientific leadership and operational management of non-interventional pharmacoepidemiology studies, including studies designed to address Jazz's post-marketing requirements/commitments (PMR/PMC) to regulatory authorities. This role will also be responsible for identifying relevant epidemiology data for regulatory submissions and documents developed to support clinical development of investigational medicines in Jazz' R&D portfolio, including Risk Management Plans (RMPs), Periodic Benefit-Risk Reports (PBRERs), orphan designation applications and others. The SM will report to the Senior Director of Epidemiology.

Essential Functions/Responsibilities

• Conduct/outsource literature searches