Information Records Associate

This position will provide colleagues the opportunity to learn the regulatory records management business and gives colleagues the opportunity for professional growth in a rapidly growing area critical to the support and defense of Vertex’s business.

Information Records Associates organize/manage information systems and processes that are used to store, analyze, and retrieve data for customers across the enterprise. They work primarily with electronic systems to archive and research the information that is required. Information Records Associate(s) handle all types of information including Regulatory, Clinical, Non-Clinical and GLP records. This role will provide support for records lifecycle management and internal/external information queries for customers and clients.

Key Responsibilities
· Collaborates with IRM team members, Quality Assurance, Library, Clinical, Non-Clinical and Regulatory personnel
· Capture metadata into various record management systems for later retrieval
· Scan documents into EDMS software to facilitate disaster recovery requirements as well as serving Vertex personnel
· Supports compliance activities for internal and external inspections and audits as appropriate
· Supports cross-functional project teams managing budgets to deliver technical and operational solutions to implement process improvements
· Support customer requests for records in a timely and cost effective manner
· Carry out complex searches across various Vertex systems to ensure retrieval of complete and accurate information as appropriate for customer request
· Track and report progress on ongoing projects to customers and IRM management
· Supports IRM record management processes as applied to business records generated during the drug development process
· Supports project lead in prioritization of activities for the effective execution and delivery of strategic imperatives related to information management systems
· GLP Archivist and/or backup

Minimum Requirements:
· BA or BSc preferred
2-4 Years of records management experience
· Undergraduate degree or relevant experience in library science or Computer Information Systems
· Significant knowledge of the drug development process, regulatory affairs, and records management in a regulated environment
· Experience working in regulated environments and knowledge of GxP and 21CRF part11
· Proven written and oral communication skills
· Demonstrated ability to maintain confidentiality
· Ability to support several projects simultaneously
· Ability to lift 40lbs

Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, cystic fibrosis, inflammation, autoimmune diseases, cancer, and pain.