General Dynamics Information Technology – Federal Civilian Division is looking for a Submissions Specialist to join our team to support the Department of Army. This position is based in the Ft. Detrick and Frederick, Maryland areas.
In this role, the Submissions Specialist will:
Prepare regulatory documents for electronic publishing and submission in compliance with all FDA regulations, best practices and guidance.
Ensure that FDA submissions are accurate, consistent and conform with the FDA Data Standards catalog.
Prepare and send documents to the FDA for all sponsored trials.
Use standardized publishing, validation and viewing software to ensure that documents meet all applicable FDA submission standards according to electronic Common Technical Document (eCTD) formats.
Collaborate with the team to ensure quality documentation and standardized practices for FDA submissions.
Ensure accurate archival of regulatory documents.
Collect and assemble regulatory documents such as applications, amendments, supplements, and reports for a variety of drugs, vaccines, and devices.
Perform post-submission and tracking tasks.
Participate in special projects as required.
Bachelor’s Degree in a related discipline, or the equivalent combination of education, professional training, or work experience.
5 years of related experience in preparing regulatory documentation submissions.
Experience with Liquent Insight eCTD Publishing software, preferred.
Excellent Microsoft Office Skills.
Excellent written and oral communication skills.
Must be U.S. citizen and be able to obtain a TI (Public Trust).
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.