摘要
About the Role
Major Accountabilities:
- Ensuring PCS compliance with training records, CV, and JDs.
- Ensure all documentation is consistent with GLP requirements.
- Support periodic review and maintenance of PCS SOPs.
- Maintain good working knowledge of any company SOPs that influence or impact the PCS SOPs.
- Get necessary input/feedback from relevant stakeholders to keep documentations up-to-date·
- Create and perform quality checks on SEND packages for FDA submissions
- Support electronic laboratory notebook compliance ensuring the necessary reviews and compliance with company guidelines
- Support the Study Quality and Compliance team’s effort for tracking and managing study-related information in a global online fashion by leveraging the use of software tools to enhance productivity and information sharing.
Minimum Requirements:
- Graduate/ Postgraduate in Life Sciences with 10-15 years relevant experience working in pharmaceutical GLP setting.
- Good working knowledge of regulatory compliance requirements
- Knowledge of animal welfare requirements related to study conduct
- Previous experience creating and reviewing SEND packages
- Good communication skills, and excellent logistical/planning skills
- Previous experience with software for online information and program management is a plus
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
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
