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

Arcetyp LLC•Gaithersburg, MD

29d•Onsite

About The Position

Arcetyp LLC is seeking a Senior DoD Medical Product Program Manager - Clinical & Regulatory. This role supports product/project management of various medical products and clinical protocols within the US Federal Government and US Military sectors. The position involves developing and reviewing regulatory documentation, coordinating FDA/IRB activities, and leading interdisciplinary teams. Arcetyp LLC is a growing small business providing consulting services in Management & IT Consulting, Program & Project Management, and Professional & Admin Services. They are looking for direct hire W2 employees only and cannot sponsor H1B visas. This position is located in Fort Detrick, MD.

Requirements

Knowledge of cGCP, cGLP, cGMP and Title 21 CFR.
Ability to support IND regulatory requirements.
Strong technical writing and stakeholder coordination.
FDA-regulated medical product development.
Investigational products.
Clinical protocol/project management.
Regulatory affairs and technical documentation.
DoD medical acquisition environment.
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.