摘要
To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities – all to bring our medicines to patients even faster.
We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to.
Apply today and welcome to where we thrive together!
About the Role
Major Accountabilities:
This role offers hybrid working, requiring 3 days per week/ 12 days per month in our White City, London office.
As Global Labelling Compliance Project Lead, you will be responsible for:
- The tracking, data mining, monitoring and reporting on the global implementation of safety related product information changes e.g. Core Data Sheet amendments and updates. This includes routine interaction and follow-up with Country (CO) and Regional Regulatory Associates and other cross-functional teams, including Quality Assurance (QA), Process Improvement & Excellence (PIE) and Technical Operations.
- Routine compliance reporting for global and local regulatory milestones of the Novartis safety label change process; support root cause analysis for any delays or non-compliance.
- Supporting internal Pharmacovigilance (PV) CO audits, interacting with the COs to ensure timely and current safety label change (SLC) compliance data and reports are provided.
- Supporting local and global PV inspections through preparation of requested SLC data and reports as required.
- Supporting the evolution and maintenance of the Novartis safety label change tracking tool (SALTO) and related projects as a SALTO Super User.
- Providing input for process improvements, training manuals and materials, IT labelling projects and user testing.
- Supporting development of Novartis systems and company projects.
Your Experience:
- Bachelor’s degree required with relevant regulatory and/or technical experience gained in the pharmaceutical industry.
- Knowledge of Regulatory Affairs, specifically labelling regulations globally, labelling submission business processes and related tools.
- Proven knowledge of data analysis and reporting, excellent verbal and written communication skills, technical/IT skills and proven ability to be innovative and a creative problem solver with quality and compliance approach.
- Fluency in English as a business language required.
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.