Henry M. Jackson Foundation Frederick , MD 21705
Join the HJF Team!
The Henry M. Jackson Foundation (HJF) is looking for a Documentation 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.
Maintain accurate and complete sponsor regulatory files for medical products
Compile accurate copies of the sponsor regulatory files for products
Assess the current paper and electronic regulatory records; interface with personnel to determine needs and requirements; and develop a plan for improving the overall quality and completeness of regulatory documents; this plan will include transition of all files to storage within an electronic document management system
Be responsible for executing the plan developed: accomplishing the organization and completion of complete paper and electronic regulatory files for medical products according to applicable regulations and policies
Evaluate and develop plans for storage and organization of project management documents
Arrange and coordinate the storage and retrieval of important files and regulatory documents, including regulatory filings and correspondence, clinical files (i.e. clinical trial master files), nonclinical files (e.g. study reports, lab notebooks, specimens), manufacturing files, and other relevant files
SKILLS AND EXPERIENCE:
Experience in FDA-regulated documents and use of electronic document management systems.
Basic understanding of the roles and responsibilities of all parties involved in the development of medical products (drugs, biologics, and devices) and 21 CFR Parts 58 and 312 regulations, OECD principles and ICH guidelines (ICH E6) associated with the management of essential non-clinical and clinical records
MINIMUM EDUCATION: A Bachelor's degree is preferred with 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.