4 security clearance jobs found

Position Summary Odyssey is looking for a Regulatory Affairs SME 2 , to support the Defense Health Agency (DHA) at Ft. Detrick, MD.  The Regulatory Affairs Subject Matter Expert 2 acts alongside RA SME 1 to provide specialized regulatory guidance and technical expertise for WPAC initiatives. This expert works to ensure compliance with all federal regulatory requirements and supports the successful development and submission of acute care medical products.   ***Contingent upon contract award*** Responsibilities Duties include, but are not limited to: Provide expert advice and guidance on the application of FDA regulations to the development of military-relevant medical solutions. Develop and review regulatory strategies, submission planning, dossier preparation, and communication with regulatory agencies. Prepare and review regulatory submissions including INDs, NDAs, PMAs, and 510(k)s. Evaluate and interpret...

Position Summary Odyssey is looking for a Regulatory Affairs Support (Warfighter Expeditionary Medicine and Treatment)  to support the Defense Health Agency (DHA) located at Ft. Detrick, MD.   This Regulatory Affairs Support SME provides specialized guidance and in-depth expertise on FDA regulatory requirements for the WEMT division. This technical resource ensures successful product development, submission, and lifecycle management for drugs, biologics, and medical devices utilized in expeditionary medicine.   ***Contingent upon contract award*** Responsibilities Duties include, but are not limited to: Provide expert advice and guidance on the application of FDA regulations to the development of military-relevant medical solutions.   Develop and review regulatory strategies, submission planning, dossier preparation, and communication with regulatory agencies.   Prepare and review regulatory...

Position Summary Odyssey is seeking a Research Technician (Level II) to support research programs and projects within the Wound Infection Department’s Animal Models group at the Walter Reed Army Institute of Research (WRAIR). Responsibilities Duties include, but not limited to:  Provide technical support in the research and development of novel medical countermeasures against wound infections, specifically in animal models of wound infections. Serve as technical expert in the microbial pathogenesis and related virulence factors in animal trial protocols. Serve as technical expert in the host and immune response to immune modulation and/or infectious disease in animal trial protocols. Serve as technical expert to investigate microbial colonization and explore novel methods to mitigate infection. Assist in preparation and proper execution of animal use protocols. Maintains accurate and appropriate research...

Overview LMI is seeking a skilled Human Capital Specialist at a customer office in Bethesda, MD.   T he position requires in-person attendance at least three days per week.  Candidates should demonstrate an understanding of organizational design and workforce planning to assist in the design and development of highly visible projects. This role will be responsible for assisting communications and process specialists with templates and workflows in support of consistent messaging and organizational integration within the enterprise. Candidates must be able to acquire a Public Trust clearance.     You will play a role in maintaining and modernizing human capital processes, designing engaging training materials, and supporting the execution of facilitated sessions. The ideal candidate is a fast learner who bridges the gap between traditional HR/learning & development and digital transformation   LMI is a new breed of digital...