Senior Force Health Protection Product Manager

Kapili Services, LLC; Frederick (MD); On-site; USD 120,000 - 170,000; Full time

Job summary

Bering-Alaka`ina Holdings, LLC is seeking a senior consultant to provide Force Health Protection program management support for a government contract at Fort Detrick, MD. The role involves regulatory coordination, training, and documentation to support IND products and FDA pathways.

The candidate will interact with DoD medical staff and DHA, preparing technical reports and coordinating with IRBs while ensuring compliance with federal regulations. Domestic and international travel may be required.

Qualifications

• Must possess a medical degree, doctorate, other advanced degree, or certification in a medical, scientific, or technical field related to the specific area of medical product development.
• Must be willing and able to obtain country/region specific vaccines/immunizations for international travel as needed.
• Must have capability to apply knowledge of DoD acquisition, force health protection, and regulatory product development.
• Must understand cGCP, cGLP and cGMP and CFR 21 for IND protocols.

Responsibilities

• Provide Force Health Protection (FHP) Program/Project Management Support.
• Develop necessary regulatory documentation and provide annual and refresher GCP training to medical staff.
• Provide training on IND products and regulatory pathways for DoD personnel.
• Coordinate with IPT and working groups; gather and analyze complex information for therapeutics, diagnostics, and clinical protocols.
• Review technical documents and ensure regulatory requirements are met for investigational products.

Skills

DoD acquisitions knowledge

cGCP/cGLP/cGMP

Regulatory documentation

IRB coordination

Education

Medical degree or higher

Job description

Bering-Alaka`ina Holdings, LLC is seeking a senior consultant to provide Force Health Protection program management support for a government contract at Fort Detrick, MD. The role involves regulatory coordination, training, and documentation to support IND products and FDA pathways.

The candidate will interact with DoD medical staff and DHA, preparing technical reports and coordinating with IRBs while ensuring compliance with federal regulations. Domestic and international travel may be required.