Novartis Regulatory Writer Job For Life Sciences – Applications Invited
Novartis Regulatory Writer Job For Life Sciences – Applications Invited. BSc and MSc Life Science candidates apply online for an Associate Regulatory Writer position that is available at Novartis. Novartis is hiring bsc/msc candidates, as per the details below in their Research & Development area:
Job Title: Associate Regulatory Writer
Job ID: 290581BR
Division: Global Drug Development
Business Unit: GDO GDD
Employment Type: Full-time
Your responsibilities consist of but not limited to:
- Act as a member of clinical trial teams following protocol finalization
- Write/edit clinical study reports or parts thereof with minimal supervision.
- Participate in the planning of analysis and data presentation to be used in study reports, initially in conjunction with the mentoring medical writer.
- Act as documentation consultant in clinical trial teams, initially in conjunction with the mentoring medical writer, to ensure compliance of documentation to internal company standards and external regulatory guidelines.
- Act as a liaison between clinical trial teams and publishing to ensure timely delivery of final documents for publishing, under supervision.
- Supervise outsourcing to external medical writers, if necessary in conjunction with the mentoring medical writer.
- Assist with preparation of parts of CTD summaries under the supervision of more senior medical writer.
- Minimum university life science degree or relevant equivalent background.
- Excellent written and oral English skills.
- Basic data interpretation and presentation skills.
- Understanding of statistics.
- Good document creation and editing skills.
- Basic knowledge of clinical documentation. Basic knowledge of clinical development.
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