Technical Advisor Support – WPAC

Goldbelt, Inc.; Frederick (MD); On-site; USD 100,000 - 140,000; Full time

Job summary

Goldbelt Apex in Frederick, MD, seeks a Technical Advisor Support – WPAC to provide scientific and regulatory expertise for medical product development.

You will support clinical research strategy, review regulatory packages, and serve as SME on IPTs, delivering technical reviews and leadership briefings.

Travel up to 20% is expected; the salary range is $100,000–$140,000 yearly with a comprehensive benefits package.

Qualifications

• Medical degree or higher in a medical/scientific/technical field.
• DoD acquisition knowledge applied with clinical expertise.
• Travel up to 20%.

Responsibilities

• Provide scientific/medical/technical expertise supporting medical product development.
• Support clinical research strategy, planning and execution of trials.
• Review IND/IDE, regulatory submissions, clinical data, CMC and technical docs.
• Act as technical SME on IPTs and cross‑functional teams.
• Provide written reviews, briefings and recommendations to product managers and leadership.

Skills

Medical product development

Clinical research

FDA regulatory

Technical analysis

Technical writing

Education

Medical degree / doctorate

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 Technical Advisor Support – WPAC.

Responsibilities

Essential Job Functions

• Provide scientific/medical/technical expertise supporting medical product development.
• Support clinical research strategy, clinical trial planning and execution.
• Review IND/IDE packages, regulatory submissions, clinical data, CMC and technical documentation.
• Participate as technical SME on IPTs.
• Provide written technical reviews, briefings and recommendations to product managers and leadership.

Qualifications

Necessary Skills and Knowledge

• Medical/scientific product development.
• Clinical research.
• FDA regulatory environment.
• Ability to analyze complex technical/scientific information.
• Strong technical writing and briefing skills.

Minimum Qualifications

• Medical degree, doctorate, other advanced degree, OR certification in a medical, scientific or technical field related to the specific medical product development area.
• Ability to apply DoD acquisition knowledge in conjunction with technical/clinical expertise.
• Travel: Up to 20%

Preferred Qualifications

• Current WPAC Technical Advisor incumbent.
• DoD/DHA medical product development.
• Combat casualty care/acute care experience.
• FDA/IND/IDE experience.
• Clinical research and CMC experience.

Pay and Benefits

The annual salary for this position is $100,000 to $140,000.

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.