Clinical Documentation Innovation Project Lead

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About the role

• 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 approp

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