Novartis
Associate Regulatory Writer Minimum university life science degree or relevant
equivalent background
Your
responsibilities include, but are 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 planning of analysis and data presentation to be used in study
reports, initially in conjunction with mentoring medical writer.
•
Act as documentation consultant in clinical trial teams, initially in
conjunction with mentoring medical writer, to ensure compliance of
documentation to internal company standards and external regulatory guidelines.
•
Act as 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 mentoring medical writer.
Minimum
requirements
•
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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