The Technical Subject Matter Expert (SME) will support the U.S. Army Medical Materiel Development Activity (USAMMDA) in the Warfighter Protection and Acute Care (WPAC) Project Management Office (PMO). This position is located at Fort Detrick, Maryland. Responsibilities are as follows:
- Serve as a SME in the area of Blood and Blood Products, Blood Research, and other Combat Casualty Care Products or Devices to include traumatic hemorrhage, brain injury, hematology, and transfusion medicine.
- Provide top level technical expert support to WPAC and work closely with the advanced development team to support the DoD acquisition requirements for medical product development.
- Act as integral member of Integrated Product Teams (IPT) in support of medical product development and acquisition in the combat casualty care product portfolio.
- Actively involved in the review process of clinical protocols and associated clinical trial documents, various regulatory applications, DoD acquisition documentation and Food and Drug Administration (FDA) documentation.
- Perform highly specialized technical tasks including design and evaluation of non-clinical studies, clinical trial designs, review of non-clinical study reports, and technical inputs into the chemistry, manufacturing and controls of biologics, drugs and devices.
- Successfully communicate with personnel at various echelons through the use of effective interpersonal and communication skills.
- Support numerous efforts and effectively prioritize and multi-task requirements.
- Maintain current knowledge of relevant technology and industry developments.
- Participate in various meetings both internally and externally to the organization.
- Attend and participate in periodic site visits, off-site meetings and briefings, sub-working group meetings and investigator meetings.
- Participates in special projects as required.
- Masters’ Degree in related scientific discipline; Ph.D. preferred.
- 6+ years of related experience.
- Experience in medical product development.
- Experience with various stages of FDA-regulated product development.
- US Citizen.
- Ability to obtain T1 (Public Trust) – NACI Clearance.
- Must be able to pass background and drug testing.
- THIS IS A FEDERAL CONTRACT.
- Position may be flexible (remote work, hours, part-time/full-time) for the right person.
About Allied Technologies and Consulting
Allied Technologies and Consulting, LLC is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
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