Regulatory Data Technical Advisor

Job Summary

Regulatory Data Technical Advisor is a full-time position responsible for providing acquisition and contracting support in the Medical Countermeasures field, focusing on data quality and compliance management for nonclinical research within BARDA's programs.

Key Responsibilities

• Serve as a technical subject matter expert for CDISC SEND and SENDIG-AR (2019) and develop validation criteria for DCC ingestion of SEND datasets
• Support the design and implementation of DCC data architecture and metadata governance frameworks, ensuring alignment with regulatory expectations
• Coordinate with project teams to establish data management plans and ensure data quality and completeness from contract research organizations

Required Qualifications

• Advanced degree (e.g., Ph.D., M.P.H., M.S.) in biological and/or chemical sciences
• Minimum eight (8) years of relevant industry and/or postdoctoral experience in regulatory data standards and analytics
• Direct SEND implementation experience
• Client-focused approach with the ability to prioritize workload in a hybrid/remote work environment