GDITs Military Health team is hiring various levels of Regulatory Affairs
Scientists 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, and medical and regulatory writing support for FDA-regulated drug, biologic, medical device, and combination products. Learn More HERE
The Regulatory Affairs Scientist will ensure compliance with FDA Sponsor responsibilities, serve as a subject matter expert for regulatory strategy, to include identifying and mitigating risk, and provide support to integrated project teams and working groups.
What Youll be Doing:
Provide subject matter expertise on all regulatory matters related to assigned regulatory projects; ensure leadership and the sponsor’s representative are kept current on the progress of the program through periodic reports
Provide regulatory support to an integrated product team or working group, which includes working with the team members, advising the team of any FDA-related activities and issues, and attending meetings, updating leadership and the sponsor’s representative through routine reports
Lead the development of a written regulatory strategy and provide to the Government. The strategy shall describe the regulatory pathway for FDA regulatory approval/licensure/clearance, any possible post-marketing commitments, and shall also describe the target product profile or equivalent that can be used throughout the development process that will describe how a product will be utilized by the end user and provide to the Government.
Identify and mitigate regulatory risk through a project Risk Register
Serve as the primary contact with the FDA; review, analyze, and respond to FDA communications and meetings by the regulatory deadline
Lead the development, organization, and structure of regulatory submissions and meeting minutes in EDMS
Coordinate, prepare, write, review, obtain, maintain, and archive the required documents for regulatory submissions
Assist in writing and/or reviewing abstracts, papers, and publications, which shall be written in collaboration with the study team members and submitted to all appropriate approval authorities
Confirm the need for registration, based on regulation and Army policy, and provide regulatory support for data entry and quality assurance of ClinicalTrials.gov information/entries, a Web-based resource that provides information on publicly and privately supported clinical studies on a wide range of diseases and conditions
Review and provide written critical regulatory feedback on acquisition milestone decision briefings, progress reviews, and other acquisition documents
Some travel may be required.
What Youll Need:
Bachelor’s Degree or the equivalent combination of education, professional training, or work experience.
2- 8+ years of experience required: leading the development of writing regulatory strategies for FDA, communicating and responding to the government and FDA on submissions, identifying and mitigating regulatory risk, etc.
Must be highly organized, detail oriented, and perform independently.
Have excellent Microsoft Excel Spreadsheet skills.
Excellent written and oral communication skills.
Must be U.S. citizen and be able to obtain a TI (Public Trust).
What Would be Even Better:
Prior DoD experience.
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.