This position is based in Ft. Detrick, Maryland and is flexible for a hybrid schedule, working in the office 2 days out of the week and remotely 3 days.
The Technical SME will support the following tasks or the assigned product(s) in support of the Warfighter Protection and Acute Care (WPAC) Product Management Organization (PMO).
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
6+ years of related experience
Experience in medical product development
Experience with various stages of FDA-regulated product development
Ability to obtain T1 (Public Trust)
WHAT GDIT CAN OFFER YOU:
Challenging work that makes a real impact on the world around you
Internal mobility team dedicated to helping you own your career
401K with company match
Diverse, highly collaborative teams
Professional development, education assistance, certification and training opportunities
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About Our Work
We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.
GDIT does not have a vaccination mandate applicable to all employees. To protect the health and safety of its employees and to comply with customer requirements, however, GDIT may require employees in certain positions to be fully vaccinated against COVID-19. Vaccination requirements will depend on the status of the federal contractor mandate and customer site requirements.
GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.