Clinical Affairs Expert

vor 3 Wochen

Lausanne, Schweiz Gi Life Sciences Vollzeit

Pour notre partenaire en dispositifs médicaux, Gi Life Science recherche un(e) :

Clinical Affairs Expert

(Poste Fixe)

Taux d’occupation : 80-100%

 

Vos responsabilités :

  • Soutenir la conduite des investigations cliniques et assurer la gestion des projets d’études
  • Gérer et coordonner les partenaires d'étude (CRO, CRA, médecins), y compris les contrats, les tâches, les échéanciers et le suivi du budget
  • Assurer que les résultats de l’étude sont régulièrement rapportés en interne et soutenir la préparation de la communication externe
  • Soutenir la soumission initiale des enquêtes cliniques et les modifications post-approbation aux comités d'éthique/IRB et aux autorités compétentes (UE/États-Unis)
  • Soutenir la communication avec les comités IRB/d'éthique et les autorités compétentes (UE/USA)
  • Soutenir la mise en place d’accords juridiques/de parrainage avec les parties prenantes de l’étude
  • Contribuer à l’élaboration de la nouvelle documentation clinique (Protocole, Brochure Investigateur, Formulaire de Rapport de Cas, rapports d’études cliniques, …)
  • Contribuer au maintien de l'évaluation clinique et à la création du plan de suivi clinique post-commercialisation (PMCF) et du rapport, ainsi que des résumés des performances cliniques et de sécurité (SSCP)
  • Développer et assurer l’amélioration continue des procédures cliniques dans le cadre du système de gestion de la qualité de l’entreprise
  • Fournir des apports pour le dossier de gestion des risques, les revues de conception et la documentation technique

 

Votre profil :

  • Diplôme universitaire (PhD / MSc) en sciences de la vie, en produits pharmaceutiques, en dispositifs médicaux ou dans une discipline similaire pertinente
  • Au moins 5 ans d'expérience dans le domaine des dispositifs médicaux, classe III de préférence
  • Fonction senior en Affaires cliniques. Une expérience supplémentaire en Affaires réglementaires est préférable.
  • Solide compréhension et expérience cohérente des réglementations du secteur des dispositifs médicaux en Europe (MDR 2017/745) et les États-Unis (FDA 21 CFR 820 et 21 CFR 11).
  • Connaissance approfondie des normes internationales pertinentes pour le poste, notamment ISO 13485, ISO 14155 et ISO 14971
  • Expérience pratique de la gestion des enquêtes cliniques dans l’UE et/ou aux États-Unis
  • Expérience de travail avec les autorités compétentes en Europe et/ou aux États-Unis.
  • Langues : Anglais C1, Français un atout
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