Medical Advisor Support – WRPBH

Goldbelt, Inc.; Maryland; Hybrid; USD 100,000 - 160,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) plan with company matching

Paid time off

Job summary

Goldbelt Apex is seeking a Medical Advisor Support – WRPBH to provide medical/scientific SME support for medical devices, diagnostics, drugs, and related products. The role includes clinical management expertise for clinical research and trials.

You will review protocols, IND/IDE packages, CMC documentation, safety data, and regulatory submissions, and coordinate with FDA, EPA, DoD, DHA, and JTS as part of an IPT SME. Travel up to 20% may be required.

Qualifications

• 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.

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.

Skills

Clinical research

Regulatory strategy

Clinical trial design

FDA-regulated products

Data review

Education

Medical degree or PhD

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.

Goldbelt APEX is looking for a Medical Advisor Support – WRPBH.

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.

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.