Clinical Documentation Innovation Project Lead

• Job title: Clinical Documentation Innovation Project Lead
• 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 Clinical Documentation Innovation team as a Clinical Documentation Innovation Project Lead and you’ll contribute to driving Clinical Documentation implementation of digital solutions to enhance Sanofi’s competitive position by accelerating the preparation of ClinDoc deliverables (e.g. clinical documents, submission dossiers, translations, trial transparency and record management).

Be part of something exceptional. Our Budapest Hub has been recognized for workplace excellence, innovation, and our commitment to putting people first. See the full list of our awards at the end of this posting.

Main responsibilities:

Innovation and digital projects:

• Lead/Participate in the identification, development and implementation of tools and processes to allow a streamlined and innovative approach to ClinDoc deliverables.
• Contribute to monitor, test and recommend new technologies to manage ClinDoc deliverables, including use of Intelligence (AI).
• Lead/Coordinate or contribute to the preparation of business requirements, business rule specifications, UAT documents & execution, operational service documentation (test, training, change management).
• Lead/Participate in the development of automation services: automation, AI & Generative AI, content reuse, data & metadata management, document templates including specific clinical project components …) through evaluation and documentation of data used to generate clinical documents.

Clinical document delivery

• Manage vendor operation oversight and governance.
• Lead/Coordinate, set up and execute automation for production of clinical documents, ensuring production activities per business requirements and due dates.
• Interact with Digital and stakeholders to deliver content, data, processes in a standardized format/presentation to operational activities related to clinical document production.
• Liaise with ClinDoc users and stakeholders to develop an understanding of inputs, required outputs and process flows.
• Work with stakeholders to communicate pre-requisites for use of automation systems to manage the delivery of required inputs (i.e. SDTM, datasets for ClinDoc use, study participant list …)
• Identify data elements and map data to setup document templates.
• Provide expertise for consistent presentation of information on therapeutic area specificities with focus, standardization/harmonization, and reuse of templates across the clinical project.
• Manage on-boarding of users to automation services ensuring training and access.
• Ensure quality control of the automated draft of deliverables (i.e. CSR, narratives …)
• Track issues, manage expectations and collect metrics to measure KPIs over time.
• As Subject Matter Expert (SME), ensure appropriate communication of updated information and adequate reporting of implemented actions internally within ClinDoc, Sanofi Governance instances, as well as externally, as appropriate to suppliers and customers.

User & technology

• Lead/advise on ClinDoc users for the account on-boarding, access management and knowledge sharing for systems, tools and technologies used in the context of ClinDoc department.
• Lead/advise development and maintenance of tools and associated processes for Clinical Document operational activities (Global Portfolio and related tools, Excel macros, CDoc SharePoint site, Microsoft Power Apps, Power BI reports …)

Transversal activities

• Communicating on a regular basis advancement of project & alerting in case of specific challenges.
• Recommend process improvements that will provide efficiency for producing ClinDoc deliverables.
• Interact with ClinDoc teams and partner teams including but not limited to Pharmacovigilance, Trial Operations, Biostatistics, Medical Affairs, Digital.
• Facilitate communication flow across clinical project business teams and Digital development teams.
• Interact with external partners and vendors at the operational level.
• Embrace transformation and communicate on changes and new/updated services internally, as well as externally, to suppliers and customers.

About you

Experience:

• Good organizational skills for the management of multiple concurrent projects and/or tasks
• Proven experience to manage projects across a matrix environment.
• Experience of work in a life science R&D environment.
• Experience handling multiple tasks and be detailed oriented.
• Experience working on Digital projects.
• Experience working with service providers.
• Experience with working on eTMF / record management within clinical trials is considered a strong advantage

Soft Skills:

• Ability to work collaboratively across different cultures and time zones
• Ability to organize and conduct meetings, assign tasks, develop project/activity plans, and follow a project/activity through to completion.
• Ability to work effectively, proactively, and collaboratively in a worldwide, multi-cultural, multidisciplinary environment.
• Customer focused.
• Ability to communicate collaboratively both, written and oral.
• Adapt to changing work environment, including change in technical environments.

Technical skills:

• Excellent knowledge of MS Environment Office package (Word, Excel, SharePoint...).
• Experience in implementation of automation, in GxP environment (is a ‘plus’ if in document authoring).
• Demonstrated experience with project methodology (agile would be a ‘plus’).
• Subject matter expert on software applications and system development.
• Good knowledge/understanding of at least one among algorithms designs and programming languages or data representation formats (i.e.: Excel functions, VBA, Python, SAS, XML, JSON...).

Education:

• Master's degree or equivalent in the field of clinical data (Biostatistics & Programming, data management) or in the field digital technology.

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 2025" award winner with flexible home office policyEnjoy 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)

Office of the Year 2025 - Evolution Award

Our most recent award - Sanofi is recognized for creating an innovative workspace that supports collaboration and adaptability.

Marketing Diamond Award 2026 - Employer Branding

One of the highest honours at Hungary's prestigious Marketing Diamond Awards, recognizing excellence in employer branding.

BSC Investor of the Year 2025

Awarded by HIPA, ABSL Hungary, and AmCham Hungary for our contribution to Hungary's business services sector.

PwC Workforce Preference Survey 2025 - Top 3 Most Attractive Employers

Ranked 3rd among the most attractive employers in Hungary.

Hungarian Employer Branding Awards 2025 - Gold & Silver

Best Strategic Employer Branding Campaign (Gold) and Best Employer Branding Campaign in the Pharma Sector (Silver).

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.

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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!

Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.