DoD Medical Product Development Lead | Clinical Research & FDA

Arcetyp LLC; Frederick (MD); On-site; USD 130,000 - 210,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company matching

Paid time off

Professional development opportunities

Job summary

Arcetyp LLC is seeking a Senior DoD Medical Product Development Advisor for on-site work at Fort Detrick, MD. You will provide scientific and regulatory expertise to support medical product development and clinical research strategy, including reviewing regulatory submissions and acting as SME on IPTs.

This role emphasizes technical writing, briefing skills, and collaboration with product managers and leadership. A competitive benefits package accompanies a salary commensurate with experience.

Qualifications

• Medical/clinical or technical qualification in medical product development.
• Experience in clinical research and regulatory environments.
• Strong technical writing and briefing abilities.

Responsibilities

• Provide scientific/medical/technical expertise for medical product development.
• Support clinical research strategy, planning and execution.
• Review IND/IDE packages and regulatory submissions, clinical data, CMC and tech docs.
• Participate as SME on IPTs and provide written reviews and briefings.

Skills

Medical product dev

Clinical research

FDA regulatory

Technical writing

Briefing skills

Education

Medical degree or higher

Job description

Arcetyp LLC is seeking a Senior DoD Medical Product Development Advisor for on-site work at Fort Detrick, MD. You will provide scientific and regulatory expertise to support medical product development and clinical research strategy, including reviewing regulatory submissions and acting as SME on IPTs.

This role emphasizes technical writing, briefing skills, and collaboration with product managers and leadership. A competitive benefits package accompanies a salary commensurate with experience.