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Senior Global Labelling Coordinator

Posted 12 Jul 2024
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Work experience
0 to 7 years
Full-time / part-time
Full-time
Job function
Degree level
Required language
English (Fluent)

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Major accountabilities: 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. Your Experience: Bachelor’s degree preferred, with pharmaceutical industry experience preferably in Regulatory Affairs. Prior experience in translations management preferred. Good communication and negotiation skills. Fluency in English. Knowledge of other languages is desirable. Ability to work in a complex, cross functional working environment. 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 Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve. 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

Our purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. We also aim to reward those who invest their money, time and ideas in our company.

Other
Amsterdam
Active in 80 countries
300 employees
40% men - 60% women
Average age is 40 years