Senior Product Management Support I (Force Health Protection)

The Job Duties and Responsibilities include but are not limited to the following:

• 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.

Required Qualifications:

• 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.
• Demonstrated experience and knowledge of Current Good Clinical Practice (cGCP), Current Good Laboratory Practices (cGLP), and Current Good Manufacturing Practices (cGMP).

Preferred Qualifications:

• Advanced degree in a scientific or health-related discipline.
• Extensive experience managing IND protocols and interacting with the FDA and IRBs.