Clinical Documentation Innovation Leader
Synthorx
Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail.
This job offer is accessible to all, regardless of gender.
Job title: Clinical Documentation Innovation Leader
Location: Marcy l’Etoile
Home office possible in respect with Sanofi global policy (2 days/week). Occasional travel required
Job type: Permanent, Full time
About the job
The Clinical Documentation Transformation Leader drives the digital modernization of Vaccine Clinical Documentation solutions and processes at Sanofi. This role combines strategic leadership in tools optimization, process innovation, and change management across multiple departments. The Clinical Documentation Transformation Leader identifies business needs, develops and implements innovative solutions, and leads transformation projects from conception to delivery. Working at the intersection of Clinical Documentation, Digital, Quality, and external partners, they ensure the successful integration of new technologies while maintaining compliance with regulatory requirements. Their mission is to enhance operational efficiency through technology-driven solutions, particularly in clinical documentation management systems and emerging technologies like AI, while ensuring alignment with organizational objectives.
About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
Main responsibilities:
Innovation & Technology Assessment: Continuously monitor the Clinical Documentation tool landscape and evaluate emerging technologies to identify solutions that can modernize existing workflows
Business Case Development: Create comprehensive business cases with clearly defined scope, objectives, expected value, and measurable KPIs to justify and guide implementation of innovative solutions
Project Implementation Excellence: Establish structured governance frameworks with optimized resource allocation and robust risk management procedures to ensure successful project delivery
User-Centric Approach: Prioritize user feedback, develop comprehensive training support systems, and build key user expertise to drive adoption and maximize the value of new solutions
Quality & Process Enhancement: Implement standardized methods and performance indicators that enable regular quality assessments and continuous process improvements based on measurable outcomes
Strategic Communication Management: Develop multi-level communication strategies that effectively track progress, report achievements, and manage risks across operational and governance levels
Strategic Partnership Development: Foster cross-functional collaboration with internal departments and external vendors to build strong relationships that enhance Clinical Documentation processes
About you
Experience:
Minimum 10 years of system implementation experience within a pharmaceutical company (GxP environment)
Fluent English (Equivalent to C1 on TOEIC scale) and French
Strong understanding of clinical trial documentation requirements and regulatory standards
Knowledge of Clinical Documentation processes and systems, with understanding of how clinical documentation integrates with the broader clinical trial ecosystem
Process improvement methodologies (Lean, Six Sigma, etc.)
Expertise in Veeva document management system (Veeva White Belt certification required) or Strong knowledge of AI and LLMs solutions
Demonstrated experience in user support
Knowledge of Clinical Documentation Management
Knowledge in JIRA/Confluence
Soft skills:
Ability to work autonomously and collaboratively
Excellent interpersonal and leadership capabilities
Analytical mind and ability to solve complex problems
Strong communication skills with ability to translate technical concepts to non-technical audiences
Adaptability in fast-changing environments
Strong customer orientation and sense of service
Ability to make decisions when facing complex issues with several scenarios
Ability to prioritize daily tasks
Technical skills:
Proven experience of project/program Management expertise (Agile/Waterfall methodologies)
Ability to lead complex transformation initiatives
Skills in data analysis and KPI setting
Strong understanding of regulatory requirements for system implementation and document management
Excellent change management skills with demonstrated ability to lead complex initiatives
Experience with digital transformation initiatives
Expertise in Incident Management User support/Training Management
Expertise in risk management
Technical knowledge of advanced generative AI technologies
Experience in working with service providers relationships
Education:
Master's degree or equivalent in the field of digital technology including AI and process improvement or in life sciences with a strong affinity for tools
Languages (Mandatory):
Fluent spoken and written English (Equivalent to C1 on TOEIC scale)
Why choose us?
Bring the miracles of science to life alongside a supportive, future focused team
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally
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
Role:
Drive meaningful change across the organization by leading projects that directly impact the efficiency of our global R&D operations and accelerate the delivery of vaccines to patients
Team:
Join a dynamic team that values innovation and is committed to modernizing clinical documentation processes across Sanofi's global vaccine development programs
Site:
Enjoy the benefits of working near Lyon, combining the advantages of a major European city with easy access to the Alps, Mediterranean coast, and renowned French countryside
"This role is at the forefront of our digital transformation efforts in clinical documentation. It's an exciting opportunity for someone who wants to make a real impact on how we manage and utilize clinical data to accelerate drug development and improve patient outcomes." Florian LEBETTE
Pursue Progress. Discover Extraordinary.
Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and 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, gender identity, protected veteran status or other characteristics protected by law.
#LI-FRA #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!