• Location: Budapest  

About the job 

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 strategy 
• Identify opportunities for process improvement: interaction with global doc team, and support to global doc strategies 
• Manage stakeholder list to be used for review and distribution 
• With 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 approval 
• Management and monitoring of documentation update priorities 
• Coordinate corporate STD/GOP gap assessment with external liaison team (against regulation): material preparation, support between EL & BPO as well as monitoring 
• Support 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 metadata 
• For transversal Content Management System (CMS) QualiPSO administration, provide good documentation practices training 
• Support document change request (DCR) process – Monitoring of DCR process including pre-assessment and support doc update according to change request process 
• Management a weekly communication on Global Quality Document approval, and generate QualiPSO extraction on demand 
• Support the QualiPSO CMS BPO in the implementation of technical changes and process improvements 

About you  

Experience:  

• Approximately 3 years of professional experience in documentation, in GxP environment   

Soft and technical skills:  

• Proficient in problem-solving, attention to detail, and good organizational skills 
• Ability to work collaboratively with cross-functional teams in a flexible and proactive manner
• Strong analytical skills
• Agile thinker and learner, adaptable to complex & d