Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions.
As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health.
The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines.
Main responsibilities:
Execute administration and governance related tasks:Identify opportunities for document format improvement: Format monitoring for alignment with global strategyIdentify opportunities for process improvement: interaction with global doc team, and support to global doc strategies Manage stakeholder list to be used for review and distributionWith a focus on initiation of quality documents (QD) workflow management: share all information needed: Identify authors, applicable templates sharing, document change request (DCR) communication, Standard (STD)/requirement information sharing, draft generation in QualiPSO (ID, metadata creation), reformatting and final draft cleanup before approvalManagement and monitoring of documentation update prioritiesCoordinate corporate STD/GOP gap assessment with external liaison team (against regulation): material preparation, support between EL & BPO as well as monitoringSupport global quality documentation team and global experts: Q&A redirection on doc content to experts: Direct questions to the appropriate authors and subject matter experts (SMEs) and providing expert responses, first level answer for questions related to documentation process, data extractions, report generation, questions about QualiPSO metadataFor transversal Content Management System (CMS) QualiPSO administration, provide good documentation practices trainingSupport document change request (DCR) process – Monitoring of DCR process including pre-assessment and support doc update according to change request processManagement a weekly communication on Global Quality Document approval, and generate QualiPSO extraction on demandSupport the QualiPSO CMS BPO in the implementation of technical changes and process improvements About youExperience:
Approximately 3 years of professional experience in documentationExperience GxP environment would be a plus
Soft and technical skills:
Education:
Languages:
Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document before applying.
#Sanofi #SanofiCareers #joinSanofi #jobopportunities #careeropportunities #sscjob #Sanofi_Budapest_Hub #Budapest #LI-EUR #LI-Hybrid
Pursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!