Clinical & Regulatory Tech Advisor

Goldbelt Apex, LLC

Frederick (MD)

On-site

USD 100,000 - 140,000

Full time

3 days ago

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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

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.

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