Senior Global Labelling Coordinator
About the Role
This role offers hybrid working, requiring 3 days per week in our White City, London office.
As Global Labelling Coordinator you will be responsible for providing specialised support to RA Global Labelling Managers and the Head of Global Labelling related to the creation and maintenance of core labelling packages (including Core Data Sheets) for development programmes and marketed products including the coordination of global labelling activities according to regulatory requirements and company standards to ensure timely and compliant regulatory submissions worldwide.
You will also provide support to the Language Services team to ensure the availability of high-quality, regulatory-compliant translations required for approvals worldwide.
Key Responsibilities:
- Support the creation and maintenance of assigned labelling projects to enable worldwide regulatory submissions.
- Independently coordinate the timely delivery of compliant documentation (Clinical Overviews, Non-clinical Overviews, SCE, SCS, PSUR, published literature, Expert CVs, Signature Pages, etc.) to support regulatory labelling submissions worldwide.
- Guide and support the Global Labelling Managers, RA Managers and cross-functional experts with the review of documents to ensure compliance with regulatory requirements and company standards, including formal QC.
- Maintain current information on the labelling project in planning tools and support compliance with required timelines.
- Coordinate planning and scheduling of topics and manage logistics of the
- Global Labelling Committee and joint labelling committee/safety board meetings including overall management of meeting minutes.
- Provide support during HA inspections and audits, such as compiling and archiving documentation, etc.
- Act as administrator and superuser for regulatory and labelling-specific databases.
- Support Translation Managers by creating regulatory-compliant (bookmarks, formatting, etc.) Word and pdf files for submission to the European Medicines Agency (EMA), adhering to required timelines.
- Independently prepare submission- ready files of amended translations for submissions involving minor, non-linguistic changes.
- Manage contact and delivery with external vendors, managing all aspects of workflow, payments for non-CP translation activities.
Essential Requirements:
- Bachelor’s degree preferred, with pharmaceutical industry experience preferably in Regulatory Affairs.
- Good communication and negotiation skills.
- Prior experience in translations management preferred.
- Fluency in English (Knowledge of other languages is desirable).
- Ability to work in a complex, cross functional working environment.
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Role Requirements
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
