Senior Global Labelling Coordinator

Global Labelling Coordinator

Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives. 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!

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!

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.