Senior DoD Medical Product Program Manager – Clinical & Regulatory - Telework

Arcetyp LLC•Gaithersburg, MD

30d•Onsite

About The Position

Arcetyp LLC is seeking a Senior DoD Medical Product Program Manager with expertise in Clinical & Regulatory affairs. This role involves supporting the product/project management of various medical products, including therapeutics, prophylactics, diagnostics, and investigational products, as well as clinical protocols. The position requires developing and reviewing regulatory documentation, coordinating FDA/IRB activities, and participating in Integrated Product Teams (IPTs) and working groups. Responsibilities also include supporting IND product accountability, protocol management, technical reports, training, and stakeholder coordination. The role is for direct hire W2 employees only and cannot sponsor H1B visas. The position is located at Fort Detrick, MD, and is considered onsite.

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.