Submission Specialist - FDA

Clearance Level
None
Category
Functional Experts
Location
Fort Detrick, Maryland

REQ#: RQ125524

Travel Required: Less than 10%
Public Trust: NACI (T1)
Requisition Type: Regular
GDIT's Military Health team is hiring a Submission Specialist to support a Publishing and Document Control component of a military medical research and regulatory affairs,Office of Regulated Activities (ORA), United States Army Medical Research and Development Command (USAMRDC) 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.This position is based in the Ft. Detrick and Frederick, Maryland.Duties and Responsibilities:  
  • Maintain Sponsor Electronic Regulatory Files (SERF) repository which includes Trial Master Files (TMFs)
  • Developed a Style Guide for the Document Control group to ensure uniform and professional indexing of records
  • Maintain controlled vocabularies in use for specific metadata fields
  • Prepare eCTD submissions and submit to FDA via FDA Gateway
  • Present workshops for the Command regarding the role of SERF and its search capabilities
  • Maintain SERF Standard Operating Procedure, SERF folder structure, and Document Control Style Guide
  • Serve as backup to Archivist, assisting with preparation of boxes for permanent storage and maintenance of Archive Database
  • Develop specific goals and plans to prioritize, organize, and accomplish work
  • Develop constructive and cooperative working relationships with others, and maintaining them over time
  • Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer
  • Performs light duties and other related duties as required and assigned
Minimum Qualifications:
  • Bachelor’s degree
  • 5+ years of experience in relevant roles such as document control specialist and index control specialist
  • Must have advanced proficiency with MS Office Suite (especially MS Excel)  
  • Exceptional communicator with ability to adjust communication style to individual personalities and needs of our customers
  • Must be adept in prioritizing multiple tasks in a fast-paced customer-centric environment
  • Minimum of 1 year experience with eCTD
  • Must be U.S. citizen and be able to obtain a TI (Public Trust) clearance.
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
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About Our Work

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.

COVID-19 Vaccination

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.