Use the General Fund Enterprise Business System (GFEBS) to initiate Purchase Requisitions, execute monthly financial reports for obligations and disbursement rates, and query multiple reports.
Organize, track, and monitor multiple assigned projects for FDA regulatory and clinical support divisions.
Schedule meetings, prepare minutes and correspondence, maintain documentation using designated electronic systems, consolidate document reviews/comments, track progress against timelines and milestones, and report metrics.
Support financial planning for regulatory affairs business functions including analysis of workload and resource planning. Utilize that data to facilitate strategy development in the production of integrated, all-inclusive regulatory support proposals for the lifecycle of projects, and to determine out year pricing while ensuring operations are reimbursed according to the cost to operate the division.
Assist in reporting and tracking outputs from support plans and agreements with customers, financial execution status, progress against agreements, and manning against manning plans.
Manage all requests for regulatory support (via internal forums, meetings, or web-based, email-based systems), to include requests for Sponsorship.
Assist with the development, maintenance, and implementation of standard operating procedures, and seek methods to continuously improve organizational processes while defining and improving regulatory business procedures, as needed.
Have the ability to handle demanding situations with clarity, focus and professionalism, and to respond quickly to quick turnaround taskers.
Participate in special projects as required.
Bachelor’s Degree in Business or related discipline, or the equivalent combination of education, professional training, or work experience.
5+ years of project coordination experience.
Working knowledge of GFEBS
Prior experience supporting the DoD or other government agency.
Proficient with MS Office Suite.
Must be U.S. citizen and be able to obtain a T1 (NACI).
Familiarity with Defense Acquisition and FDA product development, preferred.
Finance/Cost estimating experience, preferred.
Experience supporting a regulatory/clinical trial setting, preferred.
WHAT GDIT CAN OFFER YOU:
Full-flex work week
401K with company match
Internal mobility team dedicated to helping you own your career
Collaborative teams of highly motivated critical thinkers and innovators
Ability to make a real impact on the world around you
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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.