Document Technologist (e-Publisher)Job DescriptionTo ensure the compilation, publishing and technical quality of clinical documents, ensuring compliance with internal and external guidelines and supporting the timely compilation of submissions to HAs.
1. Compile, integrate and publish clinical documents with state-of-the-art word processing, electronic publishing and document management systems in the Novartis Development environment.
2. Collaborate with producers of clinical document components (cross-functional line units and DOC writers and archivists) for planning, compilation, and publishing of the final product.
3. Conduct document issue resolution with customers and collaborators.
4. Perform technical quality control (electronic functionality, adherence to internal and external document standards) of clinical documents.
5. Maintain basic knowledge of current electronic publishing standards, regulatory guidelines and legal requirements.
6. Act as the Program Publisher for various programs in clinical development, to ensure publishing resources are allocated to program-specific studies.
7. Provide input to Project and Trial Teams on the "publishing-readiness" requirements for document components.
8. Provide input on process issues to DOC management as relevant.
Minimum requirements
Graduate degree in any discipline or high/ secondary school diploma and equivalent work experience in an ePublishing setting.
Fluent English (oral and written).
1. 0-1 years experience with electronic document management and/or ePublishing systems.
2. Computer literacy, including a basic knowledge of word processing, 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.
Additional Information Experience : 0 - 1 years
Job Category: Pharmaceutical/ Biotechnology
Job Location : Hyderabad
Key Skills: "Electronic document management","clinical documentation"
Job Ref code: 44523BR
Role: • Documentation/ Medical Writing • Other Pharma
If you meet the above mentioned criteria, apply online
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