Documentation Specialist in Frederick, MD at Booz Allen Hamilton Inc.

Date Posted: 7/11/2018

Job Snapshot

Job Description

Job Number: R0032488

Documentation Specialist

Key Role:

Administer, arrange, manage, track, and coordinate the storage and retrieval of regulatory documents. Control all documentation that supports regulatory requirements. Oversee word processing, revision processing, proofreading, photocopying, circulation and tracking of documents, final document distribution, and maintenance and security of regulatory documents. Use project management principles to accomplish archiving and document control goals. Maintain user-friendly archives and databases while incorporating current advances in electronic information storage technology. Develop classification systems to facilitate access to archival materials. Apply knowledge of archival and document control theory, methodology, and practices to review and apply the standards, FDA regulations, Army regulations, and industry best practices to work products.


Basic Qualifications:

-2+ years of experience with document control

-Experience with HHS-regulated documents and the use of electronic document management systems

-Experience with Microsoft Word, Excel, and PowerPoint

-Knowledge of the roles and responsibilities of all parties involved in the development of medical products, including drugs, biologics, and devices and the Code of Federal Regulations (CFR) that oversee this development, including 21 CFR Parts 58 and 312 regulations and International Conference on Harmonization (ICH) guidelines associated with the management of essential non-clinical, manufacturing, and clinical records

-Ability to obtain a security clearance

-BA or BS degree


Additional Qualifications:
-Possession of excellent oral and written communication skills
 

Clearance:

Applicants selected will be subject to a security investigation and may need to meet eligibility requirements for access to classified information.

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