Senior Product Management Support 2

Goldbelt, Inc.•Frederick, MD

About The Position

Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect. As experts in healthcare IT experts, Apex is committed to building systems for healthcare organizations to seamlessly communicate and exchange data across different systems and devices. This position is contingent upon the successful award of a contract currently under bid. Goldbelt APEX is looking for a Regulatory Affairs Support – WEMT.

Requirements

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

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.