Position SummaryOdyssey is looking for a a
Senior Product Management Support for Force Health Protection (FHP), to support the Defense Health Agency (DHA), at Ft. Detrick, MD. This role provides vital oversight of product management and clinical protocol accountability. It also manages Investigational New Drug (IND) products, ensures adherence to Good Clinical Practices (GCP), and coordinates with the FDA to support the clinical development of therapeutics and diagnostics.
***Contingent upon contract award***ResponsibilitiesDuties include, but are not limited to:- Develop regulatory documentation, organize, and provide annual and refresher Good Clinical Practices (GCP) training to medical and laboratory staff.
- Coordinate the management of clinical protocols, therapeutics, prophylactics, and diagnostics, ensuring compliance with FDA and DoD regulations.
- Work with the DHA Office of Regulated Activities to ensure IND protocols meet all regulatory requirements and support submissions to the FDA and Institutional Review Boards (IRB).
- Provide storage, protocol management, and oversee product release for FHP IND products.
- Review and analyze technical documents, making recommendations to ensure sound scientific processes are used in support of investigational products.
***Contingent upon contract award***QualificationsMinimum Required Qualifications:Citizenship: Must be a US citizen.
Clearance: Ability to Obtain NACI.
Education: Bachelor's Degree in a scientific, health, or related field.
Years of Experience: At least 8 years of full-time work experience in clinical/FDA regulatory product development.
Certifications: Demonstrated experience and knowledge of Current Good Clinical Practice (cGCP), Current Good Laboratory Practices (cGLP), and Current Good Manufacturing Practices (cGMP).
Preferred Qualifications:Education: Advanced degree in a scientific or health-related discipline.
Years of experience: Extensive experience managing IND protocols and interacting with the FDA and IRBs.
Experience with DHA/USAMMDA preferred
Location: Defense Health Agency (DHA), 1430 Veterans Drive, Fort Detrick, MD 21702
Travel: 10%
Remote, Onsite, or Hybrid: Onsite
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***Contingent upon contract award***Odyssey Benefits
