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.
Responsibilities:
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.
Education/Experience
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
To Apply:
