Summary
About the Role
- To author and review high quality clinical and safety documents: non-registration clinical Study Reports (CSR), Development safety Update Reports (DSUR), Risk Management Plans (RMP) -Core member of clinical Trial Team/participate in safety Management Team -Actively participate in planning of data analyses and presentation used in CSRs.
- Act as documentation consultant in CTTs and SMTs To ensure compliance of documentation To internal company standards and external regulatory guidelines.
- May Act as Program Writer ensuring adequate medical writing resources are available for assigned Program and consistency between documents.
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
- 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
Work Experience:
- Cross Cultural Experience.
- Operations Management and Execution.
- Functional Breadth.
- Collaborating across boundaries.
- NA.
- 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
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
TEst Hello
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
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
