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In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
Compliance Specialist with Human Research Protection Program experience
-Experience with medical and non-medical human research within the Department of Defense (DoD) and Department of Navy (DoN).
-Experience conducting headquarters- level reviews for human research studies and supporting site visits/inspections related to human research protection.
-Experience reviewing human research documentation for DoD/DoN Assurances applications.
-Familiarity with the DoN Human Research Protection Program and DoN regulations and policies.
-At least three years’ work experience in human research protection, e.g. working in an IRB office, working in a research administration office, overseeing or conducting human research activities, etc.
-Experience applying human research regulations (e.g. 45 CFR 46, 21 CFR, etc.) in medical and non-medical (i.e. social behavioral research) research.
We are a defense contracting company based in Southern Maryland that is redefining what it means to be resourceful, responsive and reachable for our customers. AVIAN LLC is a service-disabled, veteran-owned small business. We believe talent and passion generate solutions to today’s business challenges. We understand that these characteristics thrive in a business culture that embraces innovation, ...creativity and the entrepreneurial spirit.
AVIAN is headquartered in Lexington Park, Maryland with more than 190 employees located across the county. Specifically, we are supporting customers in Huntsville, Alabama; China Lake and San Francisco, California; Panama City, Florida; Lexington Park and Patuxent River, Maryland; Arlington and Quantico, Virginia.
AVIAN provides a broad range of niche expertise to more than 20 Naval Air Systems Command (NAVAIR) program offices and a total of ten prime contracts with NAVAIR, Naval Sea Systems Command and the Office of Naval Research.