Onsite Senior DoD Medical Product Development Leader

Arcetyp LLC; Bethesda (MD); Remote; USD 120,000 - 160,000; Full time

Job summary

Arcetyp LLC in Bethesda, MD is seeking a Senior DoD Medical Product Development Advisor to provide scientific, medical, and technical expertise in developing medical products for DoD programs. The role is on-site at Fort Detrick, MD and requires travel up to 20%.

You will support clinical research strategy, review regulatory documentation, and advise product teams and leadership. A medical degree or other advanced degree in a relevant field is required, along with experience in FDA regulatory

Qualifications

• Medical/scientific product development expertise.
• Experience with clinical research strategy and regulatory submissions.
• Knowledge of FDA regulatory environment and IND/IDE processes.
• Strong technical writing and briefing skills.

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 development

Clinical research

FDA regulations

Data analysis

Technical writing

Education

Advanced degree in medical/scientific field

Job description

Arcetyp LLC in Bethesda, MD is seeking a Senior DoD Medical Product Development Advisor to provide scientific, medical, and technical expertise in developing medical products for DoD programs. The role is on-site at Fort Detrick, MD and requires travel up to 20%.

You will support clinical research strategy, review regulatory documentation, and advise product teams and leadership. A medical degree or other advanced degree in a relevant field is required, along with experience in FDA regulatory