To ensure the QC, publishing and technical quality of scientific documents,ensuring compliance with internal and external guidelines and supporting the timely compilation of submissions to HAs.

Major Activities include:

1. Compile, integrate and publish nonclinical documents with state-of-the-art 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 clinical documents.
3. Interact with TS scientific personnel (Study Directors, Principal Scientists, Project Team Representatives) in the preparation, QC and publishing of nonclinical and clinical study reports and regulatory documents.
4. Conduct document issue resolution with customers and collaborators.
5. Maintain basic knowledge of current electronic publishing standards, regulatory guidelines and legal requirements.
6. May provide input and advice to project and trial teams on 'publishing readiness' requirements for document components.
7. Troubleshoot and provide solutions to basic technical and process issues.

Key Performance Indicators:

* Completion of an adequate number of nonclinical documents (taking into account complexity and size) per year in accordance with the timelines specified by TS and organization KPIs.
* Published nonclinical 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.
* Timeliness of deliverables, such that both individual document and overall project timelines are met.Ideal Background:


Education:

Undergraduate degree, preferably in scientific field or related experience.

Languages:

English fluent (oral and written)
Experience/Professional requirement:

* At least 1-3 years experience with electronic document management systems, publishing tools
* Basic knowledge of document publishing / document management including CoreDossier, Adobe Acrobat, ISI toolbox and / ISI publisher
* Good oral and written communication skills
* Basic experience in non-clinical and/or clinical report preparation and submission.
* Basic knowledge of regulatory requirements and pharmaceutical development
* Basic knowledge and compliance with the Good Laboratory Practices and Standard Operating Procedures
* Good organizational and

teamwork skills with customer focus emphasis.
* Willingness and aptitude for learning and adapting new information and innovations