Medical Advisor Support - WRPBH

Goldbelt Apex, LLC; Frederick (MD); On-site; USD 100,000 - 160,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company matching

Paid time off

Professional development opportunities

Job summary

Goldbelt Apex is seeking a Medical Advisor Support - WRPBH to provide medical SME guidance for a range of products and clinical programs. The role includes overseeing clinical research efforts and advising on regulatory submissions.

The successful candidate will review protocols, IND/IDE packages, CMC documents, safety data, and coordinate with FDA, EPA, DoD, DHA and JTS as part of an integrated project team.

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.
• Participate as a substantive IPT SME.

Skills

Clinical research

Regulatory strategy

Clinical trial design/oversight

FDA-regulated products

Data review & recommendations

Education

Medical degree / doctorate / advanced degree / related certification

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 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.