The daily management of creating, reviewing, and approval routing regulated documents.
Must be able to both follow detailed system and process directions as well as apply learnings in new situations.
Experience in electronic management systems (EDM) they use EPIC, and MS programs. Experience working in the same industry, or in a regulated environment. This individual will be working with FDA regulations where documents are governed. Candidates that have learning agility is a must. Average or alternate candidates that would be applicable would have experience/background in legal document control. Candidate must be comfortable working in/with electronic management systems (EDM).
Responsible for providing electronic document management support for multiple organizations in Translational Sciences. This role will be responsible for the end-to-end management of regulated electronic documents from initiation to archival according to standard operating procedures and guidance documents. Activities include creating documents, document quality and formatting review, and routing documents for review and approval. Activities also include supporting document QC process, managing and editing document templates, creating electronic data dictionaries, and editing electronic formatting of PDF documents.
Strong technical knowledge and experience with office and business technologies (Electronic Document Management applications; Adobe; Microsoft Office including Outlook, Excel, PowerPoint, Word, SharePoint, One Note, OneDrive; Box)
Demonstrates learning agility, especially with electronic systems
Basic understanding of toxicology and/or drug development process
Excellent attention to detail
Strong organizational and interpersonal skills
Focus on process improvement to increase quality and operational efficiency
Strong communication skills – oral and written
Strong time management and project management methodologies and skills
Ability to prioritize and manage multiple priorities in a continually changing environment
Ability to work independently, with minimal supervision
Self-motivating, resourceful, creative, and flexible
"This posting is for Contingent Worker, not an FTE"