Medical Advisor Support – WRPBH

Goldbelt, Inc.•Frederick, MD

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 Medical Advisor Support – WRPBH.

Requirements

Clinical research and medical product development.
FDA-regulated products.
Clinical trial design/oversight.
Regulatory strategy.
Ability to review complex medical/scientific data and provide senior-level recommendations.
Medical degree, doctorate, other advanced degree, OR certification in a medical, scientific, or technical field related to the applicable medical product development area.
Ability to apply DoD acquisition knowledge with relevant clinical/scientific expertise.

Nice To Haves

Current WRPBH/DHA medical advisor incumbent.
PTSD/TBI, neuroscience, neurology, psychiatry, or Warfighter performance experience.
Clinical trial experience.
FDA/IND/IDE experience.
CMC/GMP knowledge.
Military medicine experience.

Responsibilities

Provide medical/scientific SME support for medical devices, diagnostics, drugs, biologics, blood products, medical countermeasures, PTSD/TBI, or related medical solutions.
Provide clinical management expertise for clinical research and clinical trials.
Review protocols, IND/IDE packages, CMC documentation, safety data, and regulatory submissions.
Support FDA, EPA, DoD, DHA and JTS coordination.
Participate as a substantive IPT SME.