To write and/or edit under guidance high quality clinical and safety documentation or patient narratives.
About the Role
Major accountabilities:
To write and/or edit under guidance high quality clinical and safety documents: non registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Clinical Trial Registration Documents or Patient Narratives -May act as documentation consultant in CTTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.
May act as liaison between CTTs and publishing teams to ensure timely delivery of final documents for publishing.
Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Key performance indicators:
Delivery of high quality clinical and safety documents in time and in compliance with internal and external standards -Customer / partner/ project feedback and satisfaction -Adherence to Novartis policy and guidelines
Minimum Requirements: Work Experience:
Operations Management and Execution.
Functional Breadth.
Collaborating across boundaries.
Skills:
NA.
Languages :
English.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Division Operations Business Unit CTS Location India Site Hyderabad (Office) Company / Legal Entity IN10 (FCRS = IN010) Novartis Healthcare Private Limited Functional Area Research & Development Job Type Full time Employment Type Regular Shift Work No
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