Associate, Content & Records Management, Daiichi Sankyo – NJ
Associate, Content & Records Management at Daiichi Sankyo 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 regulated documentation, performs quality control of documents generated by all functional areas contributing to marketing applications and supports the training and use of company eTMF system including the DSfD. 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.
Responsibilities:
electronic records with special emphasis on legal, business and regulatory requirements.
Responsibilities:
- 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. Compile and format clinical and regulatory documents for submission to regulatory agencies in standardized format using electronic tools.
- 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. Maintain the DSPD/DSD DCC and support records management systems and processes’ compliance with domestic and international regulations, guidance’s and industry standards.
- Provide accurate and timely response to requests for information/records.
- Provide clinical and regulatory document filing, scanning/imaging and archiving services. Manage and oversee external archiving providers, including the tracking of documents between DSPD and the external archive.
- Support the authentication, organization, and posting of documents to the content management system (i.e. DSfD). Provide eCollaboration support to project teams.
- Provide training on good records management practices, policies and systems to DSPD. Provide input to AOPs and SOP to incorporate requirements related to Records and Content Management
Education/Experience:
- Bachelor’s Degree in Information Systems/Records Management, Life Science, Engineering, Business Administration, or a related area is required.
- 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.
