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Nonclinical Documentation Assistant IV
Ref No.: 16-02833
Location: Lexington, Massachusetts
Responsibilities include, but are not limited to:

Data entry of records and metadata into internal study tracking database (PIMS, Oracle) and Microsoft Excel
Assist with the management of Nonclinical documentation (reports, protocols, references, etc.) within Documentum (entering/updating properties), electronic filing (importing)
Scanning of paper files for conversion to electronic PDF files
Confirming references against documentation in 3D (Documentum) and/or PubMed database
Creating temporary endnote databases
Upload/download documents to/from a Sharepoint site
Create binders/folders for training purposes
QC of documentation
Additional documentation/administrative tasks as required

Qualifications for Job (Knowledge, Skills, and Abilities):

Strong knowledge of word processing applications, database structure, multiple computer applications: electronic document management systems (Documentum or similar applications), and regulatory submissions. Possesses the ability to work on multiple projects and documents at the same time, high level attention to detail and accuracy, and identifies inconsistencies. Fundamental knowledge of regulatory submissions, global regulatory requirements, and industry standards for the format, content, and quality of nonclinical and bioanalytical documentation, including CTD/eCTD standards.

Experienced with Microsoft Excel and PowerPoint, Adobe Acrobat, and electronic document management systems (Documentum, Sharepoint, fileshares)

Requirements for Job (Years of experience, Education, Certifications):
AS/BS (preferably in technology, sciences or information-related field) recommended. Minimum of 2 years experience in a regulated environment with hands-on experience in electronic document management systems, submissions, and/or large volume document preparation. A team player with excellent communication skills and advanced computer literacy is required. Experience in biological research and development is preferred. Proven ability to work independently and effectively handle multiple projects.