OBJECTIVES: Responsible for tracking and trending of document revision process. Responsible for maintaining performance metrics. Responsible for facilitating scheduling of training sessions for implementation of new electronic document management system. Responsible for assisting document control group with document formatting/processing, as needed. RESPONSIBILITIES: Ensure all Quality Documents meet required standards before processing documents in the Astellas Document Management System workflows. Ensure impacted stakeholders are involved in the review of new and revised Quality Documents. Deliver effective communication of requirements and standards to Authors of Quality Documents as well as to the Users of the Astellas Document Management System. Support the development, review and delivery of training materials to provide to new users of the Veeva system. Provide guidance on proper methods for writing SOP's and other Quality Documents to meet standards. Support Document Control initiatives that lead to process improvements. Respond to email inquiries and user support questions.
