Freshers invited in Novartis Healthcare for the posts of Document Technologist
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Document Technologist
Job Description:
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.
Candidate Profile:
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.
Additional Information:
Experience: 0-2 years
Location: Hyderabad
Education: any
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 89955BR
End Date: 4th Jan, 2012
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