Archiving and Document Control Specialist

Updated: February 12, 2018
Job ID: 213650
Status: Full-Time
Regular/Temporary: Regular
Location: Frederick, MD, United States

Come Work at HJF!

The Henry M. Jackson Foundation (HJF) is looking for an Archiving and Document Control Specialist, to support the US Army Medical Material Development Activity (USAMMDA) in the Regulatory Operations Branch at Ft. Detrick, Maryland.  HJF provides scientific, technical and programmatic support services to USAMMDA.

Responsibilities:                

  1. Arrange and coordinate the storage and retrieval of important files and regulatory documents related to non-clinical and clinical data (i.e., study documents, reports, lab notebooks, specimens, case report forms, etc.)
  2. Serve as POC for archiving requirements related to medical product development efforts 
  3. Generate, manage, and track controlled documents and facilitate their submission to regulatory agencies
  4. Create and maintain “user-friendly” (simple and clear), accessible, retrievable computer archives and databases, incorporating current advances in electric information storage technology
  5. Organize archival records and develop classification systems to facilitate access to archival materials

SKILLS AND EXPERIENCE:

  • Experience and judgment to plan and accomplish archiving and document control goals.
  • Basic understanding of the roles and responsibilities of all parties involved in the development of medical products (drugs, biologics, and devices) and the 21 CFR Parts 58 and 312 regulations, Office of Environmental Compliance and Documentation (OECD) principles and International Conference on Harmonisation (ICH) guidelines (ICH E6) associated with the management of essential non-clinical and clinical records
  • Knowledge of archival theory, methodology, and practice and be able to review and apply the standards and accepted professional best practices that apply to archival work

MINIMUM EDUCATION:  Desires a minimum of a Bachelor’s degree or its equivalent with at least 2-4 years of related experience

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) is an equal opportunity and 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, protected veteran status or other status protected by law.

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Director of Human Resources.

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