+ _Location:_ _Budapest_ + _Hybrid working according to local policy_ + _Job type: Permanent, full-time_ **_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 Clinical Sciences and Operation (CSO)’s Start Up Strategy team as a **Start Up Strategy Lead (SUSL)** and you will oversee the Part II submission in the context of EU Clinical Trial Regulation (EU CTR). You will work in collaboration with the appropriate stakeholders (e.g. GSM, SUSM, GRA as well as with applicable countries and vendor) to ensure that submission in CTIS is completed in accordance with the plans and with respect to quality and timelines. **Main responsibilities:** + _Manage activities specifically related to the Clinical trials under the EU Regulation and its operational processes in the Clinical Trial Information System (CTIS). Oversee CTIS related activities performed by Study Start Up (SSU) Administrative team (CTA-CS)_ + _Align with CTA Manager in GRA and communicate the strategic Part II submission plan. With a risk management mindset, escalate risks and prepare appropriate preventative and mitigation plans_ + _Follow up/monitor CTA operational planning activities and on submission and approval of CTA package with affiliates / partners. Ensure distribution preparation and tracking submissions for all entities_ + _Daily monitor any new activities_ + _Manage and oversee activities related to tools /Sanofi Regulatory document and registration tracking tools (Vault Regulatory Information Management (RIM))_ + _Manage activities related to documentation:_ i _n close collaboration with the Clinical trial team, the Regulatory team (follow, check, and ensure availability of documents for Initial Clinical Trial Applications (CTA) preparation, CTA amendments, etc)_ , c _oordinate translation requests if needed and coordinate content owner review of materials for feedback and revision._ + _Communication:_ _Be the Point of Contact (POC), for the EU CTR part II management: the SSL is responsible for the coordination of the collaboration between EU CSU SUSM at country level, study COSL and GRA team for any part II activity, monitoring and ensuring country readiness for the study submission allocated and CTIS entry_ + _Promptly escalate to the CSU SUSM any potential impact that may affect the country SIV timelines and delivery_ + _Performance and quality/continuous improvement:_ _Review performance for every study and implement process improvement initiatives_ **About you** **Experience:** + At least 3 years as a Clinical Research Project Manager or equivalent, ideally with at least 2 years of Clinical Trial Start-Up experience + Knowledge in Clinical Development Process, and of development in recent technology and how to utilize to optimize outcomes, regulatory, ethical, and legal framework pertaining to study start-up + Experience in the Pharmaceutical Business or related industry, broad scientific knowledge across different therapy areas is a plus **Soft skills** : + Stakeholder and Interpersonal & Relationship management; + Good communicational skills, ability to work independently and within a team environment, + Experience in working with cross-functional teams, emotional intelligence + Problem-solving skills and risk management **Technical skills** : Formal training or experience in Project Management; MS Office Suite **Education** : Bachelor’s degree or higher in Life Science or equivalent **Languages** : Excellent knowledge of English language (spoken and written) **_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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Discover our Code of Conduct (https://www.codeofconduct.sanofi/) , 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 \#clinicalresearch #clinicaloperation #studystartup #clinicaltrialstartup #startupstrategy \#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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)