Senior DoD Medical Product Development Advisor - Telework

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 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.