Technical Advisor Support - WPAC

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

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company matching

Tax-deferred savings options

Supplementary benefits

Paid time off

Professional development opportunities

Job summary

Goldbelt APEX is seeking a Technical Advisor Support - WPAC to provide scientific/medical/technical expertise supporting medical product development and regulatory strategy.

The role involves supporting clinical research planning and execution, reviewing regulatory submissions, and serving as technical SME on IPTs, with strong writing and briefing skills.

Travel up to 20% and a benefits package include insurance, 401(k), and development opportunities.

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%

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 dev

Clinical research

FDA regulation

Technical writing

Technical briefing

Complex data analysis

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 comprehensive benefits package.

• medical, dental, and vision insurance
• a 401(k) plan with company matching
• tax-deferred savings options
• supplementary benefits
• paid time off
• professional development opportunities