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Under the supervision of the Document Coordinator Site Lead or Regional Lead, the Document Coordinator supports globally aligned document administration in the electronic Document Management System(s), by executing various document management tasks within the DMS. This role also provides support for paper and electronic records management and archival, according to applicable processes and within the relevant electronic systems.
Job Responsibility
Manage document processes in the electronic Document Management System (DMS)
Follows standardized, global DMS administration processes to
Review document content for compliance with template standards
Format documents
Apply release criteria, including verification of any prerequisites
Complete reference assessments for document obsoletion
Support periodic review workflows
Generate standard reports or document listings
Support for Paper and Electronic Records Management and Archival
Follows standardized, local and/or global records management processes to
Receive and process routine or audit document requests
Organize, file, log and/or retrieve paper records in onsite records facilities or in electronic document in electronic archival systems
Prepare paper documents for offsite, long-term storage or for destruction
Reconcile documents going to or coming back from offsite storage
Complete periodic reviews of trackers or onsite storage facilities
Requirements
0-2 years of experience in the pharmaceutical/biotech industry, or other highly regulated industry.
Proficiency in MS office and other software programs.
Knowledge of cGMP/GXP standards
Strong communication and interpersonal skills,
Has the ability to collaborate effectively with diverse stakeholders.