Technical Advisor Support – WPAC

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Tax-deferred savings options

Supplementary benefits

Paid time off

Professional development opportunities

Job summary

Goldbelt Apex LLC seeks a Technical Advisor Support - WPAC in the United States to provide scientific and medical expertise for medical product development and regulatory submissions. The role emphasizes DoD acquisition knowledge, clinical research strategy, and collaboration with IPTs to guide product teams.

Ideal candidates will have medical or advanced degrees, experience in FDA regulatory environments, and strong technical writing skills to deliver concise reviews and briefing materials for

Qualifications

• Medical degree or advanced degree or related certification.
• Experience applying DoD acquisition knowledge to clinical/technical contexts.
• Ability to analyze complex technical and clinical information.
• Strong written and briefing skills for regulatory and product teams.

Responsibilities

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

Skills

Medical/scientific product development

Clinical research

FDA regulatory environment

Ability to analyze complex technical

Strong technical writing and briefing

Education

Medical degree or advanced degree

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 $140,0 0.

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