Senior FHP Product Strategy Lead (DoD Health Tech)

Bering-Alaka`ina Holdings, LLC; Frederick (MD); On-site; USD 90,000 - 150,000; Full time

Job summary

Bering-Alaka`ina Holdings, LLC seeks a Senior Product Management Support Specialist to support a government customer in Frederick, MD, focusing on Force Health Protection program management, regulatory compliance, and clinical trial coordination. You will train staff on GCP, IND processes, and FDA regulations, and interact with DoD medical personnel locally and internationally.

The role requires deep regulatory expertise, DoD/FDA familiarity, and experience guiding clinical trial activities

Qualifications

• Must possess a medical degree, doctorate, other advanced degree, or certification in a medical, scientific, or technical field related to medical product development.

Responsibilities

• Provide Force Health Protection (FHP) Program/Project Management Support.
• Develop regulatory documentation and provide annual and refresher GCP training for staff.
• Provide training on INDs and regulatory pathways for DoD personnel.
• Coordinate with stakeholders to gather and analyze information for therapeutics and clinical protocols.
• Review regulatory documents to ensure compliance with FDA, CFR, DoD and DHA requirements.

Skills

Regulatory strategy

FDA/DoD regulatory knowledge

Clinical trial planning

IRB coordination

Medical product development

IND protocol understanding

Documentation and reporting

Education

Medical degree or equivalent

Job description

Bering-Alaka`ina Holdings, LLC seeks a Senior Product Management Support Specialist to support a government customer in Frederick, MD, focusing on Force Health Protection program management, regulatory compliance, and clinical trial coordination. You will train staff on GCP, IND processes, and FDA regulations, and interact with DoD medical personnel locally and internationally.

The role requires deep regulatory expertise, DoD/FDA familiarity, and experience guiding clinical trial activities