Technical Advisor Support – WPAC

Goldbelt, Inc.; Maryland; Hybrid; USD 100,000 - 140,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) plan with company matching

Professional development opportunities

Job summary

Goldbelt Apex, part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect, seeking a Technical Advisor Support – WPAC.

The role provides scientific/medical/technical expertise supporting medical product development, with responsibilities across clinical research strategy, trial planning, regulatory review of IND/IDE packages, and technical documentation, advising product managers and leadership.

Qualifications

• Medical/scientific product development experience.
• Experience in clinical research.
• Familiarity with FDA regulatory environment.
• Ability to analyze complex technical information.
• Strong technical writing and briefing skills.

Responsibilities

• 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.

Skills

Medical product development

Clinical research

FDA regulatory environment

Technical writing

Briefing skills

Education

Medical degree or higher

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.