Senior DoD Medical Product Development Advisor

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 a growing small business that provides a broad range of consulting services to US Federal Government, US Military, and Commercial clients. Services include Management & IT Consulting, Program & Project Management, and Professional & Admin Services.

We accept direct hire candidates only, W2 employee hires. We do not accept 1099 independent consultants. We do not accept staffing firms. We do not accept corp-to-corp (C2C) candidates. We can't sponsor H1B.

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. 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.

Arcetyp is an Equal Opportunity Employer and we highly value diversity of our workforce. We accept resumes from all interested parties and consider applicants for all positions without regard to race, color, religion, sex, national origin, age, marital status, sexual preference, personal appearance, family responsibility, the presence of a non-job-related medical condition or physical disability, matriculation, political affiliation, veteran status, or any other legally protected status.