CAMRIS is seeking an Animal Rule Technical Expert to join the team for a Regulatory Affairs proposal at the The Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) in Aberdeen, Maryland.
Reasonable Accommodation Statement:
To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.
- Experience in development and execution of non-clinical, toxicology and pharmacology studies, including animal model drug development plans pursuant to regulatory guidelines
- Experience in functional and drug development project leadership
- Experience in animal model development that lead to successful drug submissions, approvals
- Experience with assessing appropriateness of animal models and appropriate application of the models in relation to the MCM maturity as well as the MCM intended end use, associated regulatory risks, realism of animal model timeline, cost realism, anticipated FDA guidance, interpretation of FDA guidance and animal model non-pivotal and pivotal animal studies risk management strategies, appropriate for the level of development.
Candidates for positions under contracts with the Department of Defense (DoD) may be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency.
WORKING CONDITIONS/PHYSICAL DEMANDS:
Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Laboratory/office environment; may require working evenings and weekends. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to manipulate objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear. Work may involve long periods of standing and handling of numerous chemicals and/or hazardous biological material. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually moderate.
Masters or better in Biodmedical Science or related field