Remote Epidemiologist: Regulatory Review & Vaccine Safety

Kaiva Tech, LLC; Washington (District of Columbia); On-site; USD 120,000 - 180,000; Full time

Job summary

Kaiva Tech, LLC in the DC Metro Area seeks an Epidemiologist with extensive pharmacoepidemiology and regulatory experience to support vaccine-related regulatory reviews. The role involves data interpretation, document preparation, and communicating findings to diverse audiences.

The position requires strong scientific writing, project management, and collaboration with government stakeholders, with a strong emphasis on regulatory compliance and 508 accessibility.

Qualifications

• Minimum of seven years conducting pharmacoepidemiology studies with real-world data sources.
• Experience supporting scientific research, regulatory review, or public health programs.
• Ability to synthesize and communicate complex information to diverse audiences.
• Experience managing multiple time-sensitive projects across stakeholders.

Responsibilities

• Support review of regulatory submissions for vaccines and biological products.
• Develop knowledge of FDA review processes and regulatory requirements.
• Prepare, edit, and quality-review regulatory and scientific documents.
• Interpret epidemiologic data from claims, EHRs, and registries.
• Assess study designs and identify data gaps for regulatory decisions.
• Communicate conclusions clearly to technical and non-technical audiences.

Skills

Pharmacoepidemiology

Regulatory science

Scientific writing

Project management

Stakeholder coordination

Education

Post-Doc Epidemiology

Job description

Kaiva Tech, LLC in the DC Metro Area seeks an Epidemiologist with extensive pharmacoepidemiology and regulatory experience to support vaccine-related regulatory reviews. The role involves data interpretation, document preparation, and communicating findings to diverse audiences.

The position requires strong scientific writing, project management, and collaboration with government stakeholders, with a strong emphasis on regulatory compliance and 508 accessibility.