Qui sommes-nous ? Nous sommes les Laboratoires Pierre Fabre, leader mondial qui allie expertise pharmaceutique et dermo-cosmétique pour accompagner les consommateurs et les patients à chaque étape de leur parcours de soins. Notre portefeuille compte plusieurs franchises médicales et marques internationales dont Eau thermale Avène, Ducray, A-Derma, Klorane, René Furterer et Pierre Fabre Oral Care. En nous rejoignant, vous intégrez une entreprise riche de sens, où la dimension humaine est essentielle. Vous devenez acteur du "We Care Movement", un mouvement qui valorise l'excellence et l'innovation au sein d'équipes passionnées. Ensemble, nous repoussons les limites de la science pour unir santé et beauté au bénéfice de tous, car à chaque fois que nous prenons soin dune seule personne, nous rendons le monde meilleur. Présents dans 120 pays et une équipe de plus de 10 000 collaborateurs, nous sommes fiers de créer un impact scientifique et humain, aujourd'hui et demain! Si prendre soin est au cœur de vos valeurs, rejoignez les Laboratoires Pierre Fabre et devenez un acteur clé du "We Care Movement". Votre mission We are hiring a permanent eTMF Specialist in Toulouse or Boulogne to join a team of 7 people under the hierarchical and functional responsibility of the Clinical Study Coordinators Manager in the R& D Medical Care department. The eTMF Specialist plays a vital role within the Clinical Development Platform by overseeing the electronic Trial Master File (eTMF) system to ensure regulatory compliance, quality control, and inspection readiness across global clinical trials. This position requires expertise in clinical trial documentation management, collaboration with cross-functional teams, and active participation in audits and inspections. Your role within a pioneering company in full expansion: * Key responsibilities in eTMF management: The specialist manages the setup, maintenance, and closeout of eTMFs, performs regular quality control checks, monitors metrics and KPIs to ensure document completeness and compliance, and approves TMF management plans for internal teams and CROs. They also handle archive management to maintain accessible and organized records. * Subject Matter Expert role: They serve as the SME by providing training and support on eTMF best practices, developing and revising related SOPs and templates, and acting as the main contact for eTMF-related queries from users, auditors, and other stakeholders. * IT system oversight and compliance: The specialist ensures compliance with validation requirements, manages system migrations and updates, creates and manages study access, assesses the impact of new system versions, and supports problem resolution and system evolution in collaboration with IT teams. DIMENSIONS, CONTEXT AND IMPLICATIONS OF THE JOB The clinical trials are mainly international and covered the therapeutic areas from Pierre Fabre portfolio, namely oncology, dermatology and rare diseases. A high level of quality and accuracy is expected by the eTMF specialist. This position is compatible with teleworking up to 2 days a week after the trial period. We offer an attractive remuneration/benefits package: Incentives, profit-sharing, Pierre Fabre shareholding with matching contribution, health and provident insurance, 16 days of holidays (RTT) in addition to 25 days of personal holidays, public transport participation, very attractive CE... Qui êtes-vous ? Your skills at the service of innovative projects: * Bachelors or masters degree or equivalent in a health sciences, life sciences or a related field. * Minimum 5 years of experience in clinical trial documentation management, with at least 3 years in an eTMF-focused role. * Hands-on experience with TMF Veeva Vault and other Veeva environments. * Strong knowledge of ICH/GCP, guidelines, quality standards and regulatory requirements. * Strong understanding of the DIA TMF Reference Model and clinical trial documentation lifecycles. * Knowledge of internal stakeholders expectations (biometry, medical, quality assurance, clinical development, pharmacovigilance, etc). * Experience with TMF metrics, KPIs, and dashboards. * Experience in vendor oversight and CRO collaboration are advantageous. * Fluent English (oral and written). La première richesse des Laboratoires Pierre Fabre, sont les femmes et les hommes qui les composent disait M. Pierre Fabre. Fiers de cet héritage, et convaincus que la diversité des parcours, des expériences et des identités renforce notre performance collective, nous nous engageons à promouvoir légalité des chances et à garantir un environnement inclusif pour tous. Dans le respect des lois en vigueur, toutes les candidatures sont étudiées avec la même attention, sans distinction dorigine, de sexe, dâge, de situation de handicap, dorientation sexuelle, didentité de genre, de croyances ou de toute autre caractéristique protégée par la loi.