Document Technologist Job Purpose (State in one sentence the overall objective of the role) To compile and add

electronic navigation to clinical documents, ensuring compliance with internal and external guidelines and supporting the timely submission of the documents to the health authorities (HAs). Major Activities (Describe the 5-7 main results of the role to be achieved) 1 In collaboration with the clinical teams, compile, integrate and publish clinical documents with word processing, electronic publishing, and document management systems in the Novartis Development environment. 2 Perform technical quality control (electronic functionality, adherence to internal and external document standards) of published documents. 3 Maintain basic knowledge of current electronic publishing standards, regulatory guidelines, and legal requirements. 4 Act as the Program Publisher for various programs in clinical development to ensure publishing resources are allocated to program-specific studies and submissions. 5 Provide input and advice to project and trial teams on the publishing-readiness requirements for document components. 6 Provide input on process issues to Document Management as relevant. Key Performance Indicators (Indicate how performance for this role will be measured) 1 Publish an adequate number of clinical documents (taking into account complexity and size) per year in accordance with department standards and organization KPIs. 2 Published clinical documents meet current internal and external quality standards for electronic and/or paper HA submissions, including minimizing publishing-related technical QC findings and no rework once finalized. 3 Timeliness of deliverables, such that both individual document and overall project timelines are met. Job Dimensions (Indicate key facts and figures) Number of associates: - None Financial responsibility: (Budget, cost, sales, etc.) - None Impact on the organization: -Timely submission of high quality clinical documents to DRA and health authorities.Minimum requirementsIdeal Background (State the preferred education and experience level) Education and/or professional experience: Undergraduate degree in library science, information technology, life sciences or related areas; or high/ secondary school diploma and equivalent work experience in a pharmaceutical industry ePublishing setting. Languages: Fluent English (oral and written).

Experience / Professional Requirements: 1. 0-2 years experience with electronic document management and/or ePublishing systems. 2. Computer literacy, including a basic knowledge of Microsoft Office, document templates and electronic document and file management systems. 3. Basic knowledge of clinical documentation and regulatory requirements helpful. 4. Good organizational and project management skills. 5. Good interpersonal and communication skills.