5-7 years of experience in blood products and transfusion medicine
Expertise in combat casualty care and traumatic hemorrhage
Strong background in medical product research and development
Familiarity with FDA regulations for medical products
Experience with clinical and nonclinical studies
Ability to conduct independent technical analysis
Responsibilities
Serve as the senior subject-matter expert in blood products and transfusion medicine
Advise product managers on advanced medical product development
Support clinical and nonclinical programs, including regulatory strategies
Review technical and regulatory documentation for compliance
Participate in Integrated Product Teams (IPTs) and communicate risks to leadership
Benefits
Comprehensive medical, dental, and vision insurance
401(k) plan with company matching
Tax-deferred savings options
Paid time off
Professional development opportunities
Full Job Description
Arcetyp LLC is looking for a Blood Products & Transfusion Medicine SME. This position is onsite and located in Fort Detrick, MD.
ESSENTIAL JOB FUNCTIONS:
Serve as senior SME in blood/blood products, blood research, blood operations, combat casualty care, traumatic hemorrhage, hematology and transfusion medicine.
Advise product managers on advanced medical product development.
Support clinical/nonclinical programs, regulatory strategies, CMC, testing, fielding and training.
Review technical and regulatory documentation.
Participate as senior SME on IPTs and communicate risks/recommendations to leadership.
NECESSARY SKILLS AND KNOWLEDGE:
Blood and blood products.
Transfusion medicine/hematology.
Combat casualty care and traumatic hemorrhage.
Medical product research/development.
Clinical/nonclinical studies.
FDA-regulated medical products.
MINIMUM QUALIFICATIONS:
Demonstrable subject-matter expertise in blood/blood products, blood research/operations, transfusion medicine and/or combat casualty care.
Ability to provide independent senior-level technical analysis and recommendations.
PREFERRED QUALIFICATIONS:
Current WPAC Blood SME incumbent.
Military blood program experience.
Combat casualty care product development.
FDA biologics/drug/device experience.
CMC experience.
DoD acquisition lifecycle experience.
Ability to travel up to 30%.
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.
