Senior DoD Medical Product Development Advisor

Arcetyp LLC; United States; On-site; USD 140,000 - 200,000; Full time

Job summary

Arcetyp LLC in Fort Detrick, MD, is seeking a Senior DoD Medical Product Development Advisor to provide scientific and medical expertise across product development, clinical strategy, and regulatory planning.

The role encompasses reviewing IND/IDE packages, serving as SME on IPTs, and delivering technical reviews and recommendations to product managers and leadership.

Qualifications

• Must have medical/scientific product development experience.
• Clinical research experience required.
• Familiarity with FDA regulatory environment beneficial.

Responsibilities

• Provide scientific/medical/technical expertise for medical product development.
• Support clinical research strategy, trial planning and execution.
• Review IND/IDE packages, regulatory submissions, clinical data, CMC, and docs.
• 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/regulatory

Technical writing

Data analysis

Education

Medical degree or advanced degree

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. 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.

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.