DoD Health - Blood Products & Transfusion Medicine SME - Telework
About The Position
Arcetyp LLC is seeking a Blood Products & Transfusion Medicine Subject Matter Expert (SME) to provide consulting services to US Federal Government, US Military, and Commercial clients. This is a direct hire, W2 employee position. The role requires serving as a senior SME in blood/blood products, blood research, blood operations, combat casualty care, traumatic hemorrhage, hematology, and transfusion medicine. The SME will advise product managers on advanced medical product development, support clinical/nonclinical programs, regulatory strategies, CMC, testing, fielding, and training. Responsibilities include reviewing technical and regulatory documentation and participating as a senior SME on Integrated Product Teams (IPTs), communicating risks and recommendations to leadership. The position is located in Fort Detrick, MD, and is an onsite role with potential for telework.
Requirements
- Blood and blood products.
- Transfusion medicine/hematology.
- Combat casualty care and traumatic hemorrhage.
- Medical product research/development.
- Clinical/nonclinical studies.
- FDA-regulated medical products.
- 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.
- U.S Citizenship.
Nice To Haves
- 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.
Responsibilities
- 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.
Benefits
- medical, dental, and vision insurance
- a 401(k) plan with company matching
- tax-deferred savings options
- supplementary benefits
- paid time off
- professional development opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
