Senior DoD Medical Product Program Manager – Clinical & Regulatory

Arcetyp LLC•Fort Detrick, MD

29d•Onsite

About The Position

Arcetyp LLC is seeking a Senior DoD Medical Product Program Manager - Clinical & Regulatory to support product/project management of therapeutics, prophylactics, diagnostics, investigational products, and clinical protocols. This role involves developing and reviewing regulatory documentation, coordinating FDA/IRB activities, and participating in Integrated Product Teams (IPTs)/working groups. The position also includes support for IND product accountability, protocol management, technical reports, training, and stakeholder coordination. This is a direct hire, W2 employee position, not accepting 1099, staffing firms, or C2C candidates. Sponsorship for H1B is not available.

Requirements

Knowledge of cGCP, cGLP, cGMP and Title 21 CFR.
Ability to support IND regulatory requirements.
Strong technical writing and stakeholder coordination.
U.S Citizenship.

Nice To Haves

Current FHP incumbent.
Direct experience with the existing FHP portfolio.
DHA/DoD IND management.
FDA submission and IRB coordination experience.
Prior military medical countermeasure program support.

Responsibilities

Support product/project management of therapeutics, prophylactics, diagnostics, investigational products, and clinical protocols.
Develop/review 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.
Investigational product/program management.
FDA/IRB regulatory coordination.
Clinical protocol management.
GCP training and regulatory documentation.
Stakeholder/IPT leadership.
Product accountability and technical analysis.