Technical Advisor: Medical Product & Regulatory Strategy
Goldbelt Apex LLC
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Benefits offered by this job
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
Education
Job description
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
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