Senior DoD Medical Product PM - Clinical & Regulatory

Arcetyp LLC; Frederick (MD); On-site; USD 120,000 - 180,000; Full time

Job summary

Arcetyp LLC, a growing consulting firm serving US Federal Government, is seeking a Senior DoD Medical Product Program Manager - Clinical & Regulatory. This onsite role is located at Fort Detrick, MD.

The position entails leading regulatory documentation, clinical protocol management, and coordination with FDA/IRB activities, while guiding IPTs and ensuring program accountability for investigational products in a DoD medical acquisition context.

Qualifications

• Knowledge of cGCP, cGLP, cGMP and Title 21 CFR.
• Ability to support IND regulatory requirements.
• Strong technical writing and stakeholder coordination.
• Travel: Up to 20%.

Responsibilities

• Support product/project management of therapeutics, prophylactics, diagnostics, investigational products, and clinical protocols.
• Develop/regulatory documentation.
• Coordinate FDA/IRB activities.
• Participate in and lead IPTs/working groups.
• Support IND product accountability, protocol management, technical reports, training, and stakeholder coordination.

Skills

FDA-regulated development

Investigational products

Clinical protocol management

Regulatory documentation

DoD medical acquisition

Job description

Arcetyp LLC, a growing consulting firm serving US Federal Government, is seeking a Senior DoD Medical Product Program Manager - Clinical & Regulatory. This onsite role is located at Fort Detrick, MD.

The position entails leading regulatory documentation, clinical protocol management, and coordination with FDA/IRB activities, while guiding IPTs and ensuring program accountability for investigational products in a DoD medical acquisition context.