Arcetyp LLC is looking for a Senior DoD Medical Product Development Advisor. This position is onsite and located in Fort Detrick, MD.
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.
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.
Min. Citizenship Status Required:
U.S Citizenship.
LOCATION:
Fort Detrick, MD
COMPENSATION: Pay and benefits information for this position will be provided to interested candidates that apply. Arcetyp offers a package of compensation and benefits to full-time salaried employees. Pay and Benefits from our client: 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.
