GDIT's Military Health team is hiring a Project Manager to support the Office of Regulated Activities (ORA) under the DoD (Dept. of Army) located at Ft. Detrick in Frederick, Maryland.
The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing Food and Drug Administration regulated medical products for the Warfighter. The ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring.
Organize, track, and monitor multiple assigned projects for FDA regulatory and clinical support divisions.
Attend, participate in and organize meetings. Prepare minutes and correspondence, maintain documentation using designated electronic systems, consolidate document reviews/comments, track progress against timelines and milestones, and report metrics.
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 assure that financial obligations are met as planned.
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 urgent 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.
3 years’ of related experience
Advanced Microsoft Excel, Word and PowerPoint skills.
Proficient communication skills (written and oral)
Project management skills, including the ability to be proactive, multi-task, work collaboratively in a team environment, and meet deadlines
Must be U.S. citizen and be able to obtain a TI (Public Trust)
Familiarity with Defense Acquisition and FDA product development.
Cost estimating experience
Budgeting and/or financing
Familiar with scientific and/or medical terminology
Familiar with medical research and development
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
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.