Senior Product Management Support I

Goldbelt, Inc. • Frederick, MD

1d

About The Position

Please note that this position is contingent upon the successful award of a contract currently under bid. 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. Goldbelt APEX is looking for a Senior Product Management Support I.

Requirements

• Ability to understand and apply cGCP, cGLP, and cGMP.
• Knowledge of FDA requirements and Title 21 CFR applicable to IND protocols.
• Knowledge of DoD acquisition, Force Health Protection, and clinical/FDA-regulatory product development.

Nice To Haves

• Current FHP incumbent.
• DHA Office of Regulated Activities experience.
• IND product/protocol management experience.
• IRB interaction/approval experience.
• Military medical countermeasure experience.
• CONUS/OCONUS operational support experience.

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.

Benefits

• medical, dental, and vision insurance
• a 401(k) plan with company matching
• tax-deferred savings options
• supplementary benefits
• paid time off
• professional development opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed