Clinical Trials & Regulatory Medical Advisor

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

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.