Medical Advisor Support - WRPBH

Job Description

Overview
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.

Summary:
Goldbelt APEX is looking for a Medical Advisor Support - WRPBH.

Responsibilities
Essential Job Functions:
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.

Qualifications
Necessary Skills and Knowledge:
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.
Minimum Qualifications:
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.
Travel: Up to 20%
Preferred Qualifications:
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.

Pay and Benefits
The annual salary for this position is $100,000 to $160,000.

At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.

Essential Job Functions:
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.

Requirements

Necessary Skills and Knowledge:
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.
Minimum Qualifications:
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.
Travel: Up to 20%
Preferred Qualifications:
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.

Pay and Benefits
The annual salary for this position is $100,000 to $160,000.

At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.