Senior Product Management Support (Force Health Protection)

Position Summary

Odyssey is looking for 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.

Responsibilities

• 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.

Qualifications

• Citizenship: Must be a US citizen.
• Clearance: Ability to Obtain NACI