Clinical Quality Document Specialist

Job title: Quality Document Specialist Location: Budapest, Hungary Job type: Permanent, full-time Hybrid working About the job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Join our global Quality Document Management team as a Quality Document Specialist and you'll be responsible for the documentation of clinical business processes; and ensuring coherence with related process documents and compliance with the Sanofi Quality Management System (QMS) and documentation standards. You will provide Clinical Operations teams with comprehensive guidance on how to conduct clinical studies: Quality Documents (QDs) are required by international regulation to demonstrate the appropriate conduct of clinical studies and are subject to inspection by Health Authorities; Operational Documents provide detailed instructions and best practice guidelines. Main responsibilities: Organize and participate in meetings for QD deliverables, documenting outcomes/actions. Support Process Optimization Manager and SMEs, during process discussions. Write QDs (Standard Operating Procedures, Working Instructions, and associated forms), using corporate templates and writing rules. Programme process flowcharts in internal tool. Coordinate QD review and participate in discussions to resolve SME comments. Perform peer quality control (QC) of QDs; manage approval workflows for QDs in CMS; publish QDs. Support Business Authors to write/update Guidelines. Perform migration of process documents for new Sanofi entities, from legacy system to CMS, and ensure appropriate archiving of historic documents. Support inspection and audit preparation by identifying relevant QDs; and subsequently work with Quality Auditors to implement appropriate corrective and preventative actions in QDs. About you Experience: Experience Clinical Operations/Development (i.e. study management, medical writing, site monitoring, data management, statistics), initial experience in Quality role Soft Skills: Able to deploy strong interpersonal and communication skills. Quality-focussed and detail-oriented – able to control the accuracy, reliability, and quality of technical/scientific documents. Results-driven - able to multi-task, prioritize assignments and manage a wide range of operational and strategic activities in parallel. Able to analyse information, assess downstream impacts, and use deductive reasoning to solve issues and find innovative solutions. Leader and facilitator – able to deploy strong interpersonal and communication skills, to effectively lead global, multi-disciplinary team discussions. Technical skills: Basic understanding of international regulatory requirements related to conduct of clinical studies (i.e. ICH GCP guidelines). Quality Document Management Systems and Quality standards. Microsoft Office. Education: Degree level education, preferably in a scientific or medical discipline. Language(s): Strong English skills (verbal and written), ability to exchange fluently in a global environment. Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment Work from an "Office of the Year 2023" award winner with flexible home office policy Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs) Pursue Progress . Discover Extraordinary . 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 #R&D #LI-EUR #LI-hybrid Pursue progress , discover extraordinary Better 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 !