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.

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.

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