This position allows the opportunity to work REMOTE from home during COVID pandemic restrictions. Once it is safe to return to work, and restrictions are lifted, this position will work 100% onsite at Fort Detrick, Maryland.
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 support the advanced development requirements for medical products.
Act as integral member of Integrated Product Teams (IPT), decision gate meetings, program briefings, and product acquisition in combat casualty care product portfolio.
Actively involved in the review process of clinical protocols and associated clinical trial documents, various regulatory applications, and Food and Drug Administration (FDA) recommendations.
Perform highly specialized technical tasks including design and evaluation of non-clinical studies, development of non-clinical trial designs, review of non-clinical study reports, and technical inputs into the chemistry, manufacturing and controls of biologics, drugs and devices.
Work closely with the advanced development team to facilitate initial development design sessions of major product initiatives and associated activities.
Successfully communicate with personnel at various echelons through the use of effective interpersonal and communication skills.
Manage numerous efforts and effectively prioritize and multi-task requirements that have a direct impact on the Program.
Maintain current knowledge of relevant technology and industry developments.
Participate in various meetings both internally and externally to the organization.
Support the DoD Acquisition Lifecycle and document preparation.
Attend and participate in site visits, off-site meetings and briefings, sub-working group and investigator meetings.
Participates in special projects as required.
Masters’ Degree in related scientific discipline or equivalent combination of education, professional training or work experience.
10+ years of related experience.
Experience in medical product development.
Ability to obtain T1 (Public Trust).
Experience in regulatory submission (INDs, NDAs, BLAs, 510(k)s and PMAs) and guidance and management of projects related to premarket and post-market applications.
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 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.