Novartis Jobs Latest – Life Sciences Clinical Publishing Associate
Novartis Jobs Latest – Life Sciences Clinical Publishing Associate. BSc Life Science candidates apply online for a Global Clinical Publishing Associate position that is available at Novartis. Novartis is hiring bsc candidates, as per the details below in their Research & Development area:
Job Title: Global Clinical Publishing Associate
Job ID: 299188BR
Division: Global Drug Development
Business Unit: REG AFFAIRS GDD
Employment Type: Regular
Your key responsibilities:
Your responsibilities include, but are not limited to:
- Guarantee compliance with internal as well as external standards, to compile and also include electronic navigation to clinical as well as regulatory documents. Support the timely submission of documents to the Health Authorities (HAs), as well as provide publishing consultancy to the clinical teams as well as other line functions.
- In collaboration with the clinical teams, compile, integrate and also publish clinical documents with word processing, electronic publishing, and also document management systems in the Novartis Development environment.
- Perform technical quality control (electronic functionality, adherence to internal and external document standards) of published documents.
- Maintain basic knowledge of current electronic publishing standards, regulatory guidelines, and also legal requirements.
- Under direct supervision of the immediate manager, acts as the Program Publisher for different programs in clinical development.
- Guarantee published clinical documents satisfy current internal and also external quality standards for electronic and/or paper HA submissions, including minimizing publishing-related technological QC findings and no rework when finalized.
- Timeliness of deliverables fulfils both individual documents as well as overall project timelines.
- Publish clinical documents (taking into account complexity and size) in accordance with department standards and organization KPIs.
What you’ll bring to the role:
- Bachelors in life sciences or a relevant field with minimum 3 years submission publishing experience in Pharma or related industry.
- Experience with regulatory submission format, including familiarity with submission publishing activities and also CTD format requirements.
- Familiar with regulatory requirements and also HA guidances, including FDA regulations, ICH and EMA guidelines/directives.
- Proficiency with computer programs/systems (MS office, etc.) with proven ability to learn brand-new systems quickly.
- Effective interpersonal abilities, solid written and also oral communication as well as presentation skills.
- Project management and time management abilities to handle multiple ongoing projects simultaneously.
- Ability to coordinate as well as work effectively with cross-functional teams.
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