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Available Positions

Thursday, February 7, 2013

F/T - Associate/Content and Records Mgmt - Daiichi Sankyo (NJ)

Associate, Content & Records Management
Daiichi Sankyo
Edison, New Jersey

Job Summary:
We are currently seeking a Associate, Content & Records Management for our Edison, New Jersey location. This position is responsible for all duties associated with supporting the management (creation, review, approval, and reuse) of electronic documents. This job supports and maintains the integrity an standards of all DSPD/DSD regulated documentation, performs quality control of documents generated by all functional areas contributing to marketing applications and supports the training and use of company standards including the DSPD Style Guide and templates. This job is also responsible for all duties associated with supporting (filing, archival, retention and disposition) of paper and electronic records with special emphasis on legal, business and regulatory requirements and for actingas a Knowledge Management Liaison.
In this role, you will coordinate with authoring departments to finalize documents and ensure that they are submission ready and all components are compiled and presented in the correct format according to established regulations, guidelines and procedures and reflect information/data from source documents. You will compile and format clinical and regulatory documents for submission to regulatory agencies in standardized format using electronic tools and into XML documents as specified by FDA, MHRA and international standard XML document types; liaise with study teams to coordinate the flow of trial documentation to the Document Control Center (DCC).; co-ordinate and manage the receipt, classification, filing and archiving of documentation from Europe. Additionally, you will maintain the DSPD/DSD DCC and support records management systems and processes’ compliance with domestic and international regulations, guidances and industry standards; provide accurate and timely response to requests for information/records; provide clinical and regulatory document filing, scanning/imaging and archiving services; support the authentication, organization, and posting of documents to the content management system; provide eCollaboration support to project and manage and oversee external archiving providers, including the tracking of documents between DSPD/DSD and the external archive and act as a Knowledge Management Liaison for operations.
Qualified candidates must have a Bachelors Degree in Information Systems/Records Management, Life Science, Engineering, Business Administration, or a related area and a minimum of 4 years experience in a support position in records and content/document management in a pharmaceutical clinical development environment. Experience in a library or legal/scientific research support is also required. Use of contemporary document and records management technologies and systems; strong background in automated content and records management principles and systems, electronic archiving knowledge base and experience; significant industry experience in a regulated environment and familiarity/understanding of government regulatory requirements (GMP, GCP, GLP); extremely strong MS Office expertise; experience utilizing content and records management software; document scanning/imaging expertise; and significant experience supporting quality control/regulatory audits are critical skills in this role

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