Senior Force Health Protection Product Manager

Bering-Alaka'ina Holdings, LLC; Frederick (MD); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

401K plan with company match

Health insurance

Job summary

Bering-Alaka`ina Holdings, LLC is seeking a senior Product Management support specialist for Force Health Protection. The role focuses on program management, regulatory documentation, IND processes, and DoD-related clinical trial oversight at Fort Detrick, MD. Travel to CONUS/OCONUS locations may be required.

The candidate will coordinate with SMEs, IRBs, IPTs, and FDA-related activities, ensuring compliance with federal requirements for investigational products and clinical protocols.

Qualifications

• Must possess a medical degree or higher in a related field.
• Willingness to obtain vaccines/immunizations for international travel.
• Ability to interpret and synthesize DoD/Agency directives and guidance.
• Apply knowledge of DoD acquisition, force health protection, and regulatory product development.
• Expertise in medical devices, diagnostics, drugs or biologics, and related countermeasures.
• Subject-matter expertise in clinical trial site selection, setup and recruitment.

Responsibilities

• Provide FHP program/project management support and regulatory strategy.
• Develop regulatory documentation and GCP training materials for staff.
• Coordinate IND-related workflows and FDA submission processes as needed.
• Lead IPT meetings, document minutes, and prepare technical reports.
• Interact with IRBs and DoD/agency stakeholders to align with requirements.
• Review technical documents and advise on CMC, regulatory, and trial conduct.
• Assist in site selection, investigations, and site training for trials.

Skills

DoD knowledge

Regulatory savvy

Clinical trial

CMC expertise

Medical devices

IRB familiarity

Education

Medical degree

Job description

Bering-Alaka`ina Holdings, LLC is seeking a senior Product Management support specialist for Force Health Protection. The role focuses on program management, regulatory documentation, IND processes, and DoD-related clinical trial oversight at Fort Detrick, MD. Travel to CONUS/OCONUS locations may be required.

The candidate will coordinate with SMEs, IRBs, IPTs, and FDA-related activities, ensuring compliance with federal requirements for investigational products and clinical protocols.