Regulatory Document Assistant needed for major pharma, Central N

Kelly Clinical Resources is seeking a Regulatory Document Center Associate I for a 1 year contract at a major pharmaceutical company in Central NJ.

DUTIES >> Entry level position that performs all traditional document center functions(dossier compilation and dispatch, retrieval, scanning, archiving, etc.) as instructed by Regulatory Document Center personnel.
Support research requests and submission process using multiple indexing systems and provide requestors with copies of regulatory documentation. Lead for logging and filing all new documents. Assist in projects to facilitate transfer of legacy and other hard copy documents to the electronic repository. Perform data entry as needed into various tracking databases.

SKILLS >> Proven customer service skills; demonstrated team player. Knowledge of basic medical terminology preferred. Familiarity with scanning, microfilming and file structure basics. Computer literate. Some heavy lifting up to 35 lbs. may be required. Strong organizational skills. Ability to work with shifting priorities in fast paced environment to meet project requirements. Self-motivation; ability to learn.

DESIRABLE but not ESSENTIAL: Basic understanding of the document types required to support the drug development process. Working knowledge of document collection, storage and retrieval. Awareness of internal procedures and document center requirements; aware of GxPs

EDUCATION >> HS degree with some related college coursework preferred. Minimum of 1 year experience in pharma or related industry with 1-2 years experience in a high volume, federally regulated File Room.


QUALIFIED APPLICANTS ARE ENCOURAGED TO CLICK "APPLY NOW" FOR IMMEDIATE CONSIDERATION!

Kelly Scientific Resources®(KSR) is the scientific business unit of Kelly Services, a Fortune 500 staffing industry leader. We provide scientific staffing services on a temporary, project and full-time basis to a broad spectrum of industries including Pharmaceutical, Biomedical, and Clinical Research.




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