Business Analyst Senior – Expert AMM

il y a 6 jours

Saclay, France INFOGENE Temps plein

Business Analyst Senior – Expert AMM & Veeva RIM – Regulatory Affairs | Industrie Pharmaceutique Business Analyst / Expert Fonctionnel AMM – Veeva (Réglementaire) Localisation : Télétravail + Site de Saclay Date de démarrage : 1er octobre 2025 Dans le cadre du programme stratégique Holistic RIM, la DSI souhaite renforcer ses équipes avec un Business Analyst / Expert Fonctionnel ayant une expertise dans le domaine des Affaires Réglementaires (Regulatory Affairs), pour accompagner la transformation des outils AMM (Autorisation de Mise sur le Marché) via la plateforme Veeva. Objectifs du programme Holistic RIM Remplacement des outils actuels (Registration, Submission, Publishing, Archiving) par la plateforme Veeva RIM. Refonte des processus métiers liés aux AMM. Migration des contenus existants (données/documents) vers la nouvelle plateforme. Couverture : R&D World Regulatory Affairs, CMC, Industrie, Filiales. Missions principales Configuration & Spécifications S’approprier rapidement le périmètre fonctionnel et la solution cible. Participer au recueil des besoins, gap analysis, rédaction des spécifications fonctionnelles. Accompagner les activités de configuration Veeva (en mode agile). Assurer la continuité des spécifications et le suivi des arbitrages fonctionnels. Processus Métier & Impacts Contribuer à la revue des processus métiers et analyser les impacts IT. Synchroniser les streams Processus Métier et Configuration IT. Challenger les besoins métier en intégrant les contraintes techniques et fonctionnelles. Projets & Documentation Participer aux analyses d’impact, risques, chiffrages et planifications. Contribuer à la rédaction des cahiers de recette et à la validation fonctionnelle. Participer activement aux réunions projets. Livrables attendus Revue d’existant : analyse des spécifications et de la configuration logicielle. Périmètre Delivery consolidé : suivi des specs/config, cohérence fonctionnelle. Documentation associée à la migration, recette, tests. Compétences requises Fonctionnelles Solide expérience des processus AMM (Registration, Submission, Publishing, Archiving). Expertise des outils Veeva liés aux Affaires Réglementaires. Connaissance des réglementations internationales Santé / BPx. Excellentes capacités d’analyse, de synthèse, et de communication. Capacité à travailler dans un contexte multi-interlocuteurs (Métier, IT, Éditeur). Sens de la pédagogie et de la conduite du changement. Linguistiques Anglais courant indispensable (contexte international). #J-18808-Ljbffr

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