Senior Regulatory Product Manager - IND & FDA Programs

Odyssey Systems Consulting Group, Ltd.; Frederick (MD); On-site; USD 120,000 - 180,000; Full time

Job summary

Odyssey Systems Consulting Group, Ltd. is seeking a Senior Product Management Support for Force Health Protection to support the Defense Health Agency at Ft. Detrick, MD.

The role oversees product management and clinical protocol accountability for IND products, ensuring compliance with GCP and coordinating with the FDA. Contingent upon contract award, the position requires regulatory expertise and cross-team coordination with laboratories and clinical staff to enable compliant development of

Qualifications

• U.S. citizenship required.
• Ability to obtain NACI clearance.
• Bachelor's Degree in a scientific, health, or related field.
• At least 8 years of full-time work experience in clinical/FDA regulatory product development.
• Knowledge of current Good Clinical Practice (cGCP), current Good Laboratory Practices (cGLP), and current Good Manufacturing Practices (cGMP).

Responsibilities

• Develop regulatory documentation and provide annual/refresher GCP training to staff.
• Coordinate management of protocols, therapeutics, prophylactics, and diagnostics per FDA/DoD regulations.
• Ensure IND protocols meet regulatory requirements and support FDA/IRB submissions.
• Provide storage, protocol management, and oversee product release for IND products.
• Review technical documents and ensure sound scientific processes for investigational products.

Education

Bachelor's Degree in a scientific, health, or related field

Advanced degree in a scientific or health-related discipline

Job description

Odyssey Systems Consulting Group, Ltd. is seeking a Senior Product Management Support for Force Health Protection to support the Defense Health Agency at Ft. Detrick, MD.

The role oversees product management and clinical protocol accountability for IND products, ensuring compliance with GCP and coordinating with the FDA. Contingent upon contract award, the position requires regulatory expertise and cross-team coordination with laboratories and clinical staff to enable compliant development of