Engility Clinical Research/Regulatory Affairs Subject Matter Expert in n/a, Virginia
Engility delivers innovative solutions to critical challenges facing the nation and the world. As a premier provider of integrated services for the U.S. government, we support the Department of Defense, intelligence community, space communities, federal civilian agencies and international customers. Engility is dedicated to making lives better, safer and more secure.
Engility is seeking a Clinical Research/Regulatory Affairs Subject Matter Expert.
A qualified candidate will perform the following responsibilities, but are not limited to:
Directs and oversees Clinical Development/Operations and Regulatory Affairs process for aresearch and development services providerconducting clinical trials of experimental vaccines and biologics.
Develops study protocols and creates standards and guidelines for clinical research services and programs.
Ensures adherence to standard operating procedures, good clinical practice and FDA regulations.
Coordinates inspection of the organization and contract facilities, and coordinates regulatory submissions and Agency interactions.
Active/current Secret clearance is required (interim Secret is also acceptable).
Master’s Degree with at least 12+ years of experience in the field is required.
Familiarity with a variety of the field's concepts, practices, and procedures.
Must rely on extensive experience and judgment to plan and accomplish goals.
Must have a wide degree of creativity and latitude.
Performs a variety of tasks.
Must be willing to travel occasionally.
- PhD with 9+ years of relevant experience.