Early Access Project Manager

il y a 2 semaines


Paris, France HAYS Temps plein

Nous recherchons pour l’un de nos clients : un laboratoire pharmaceutique un Chef de projet Early Access
- Pour tout nouveau produit / indication (développement de laboratoire / nouvelle acquisition ou nouvel accord de licence), coordonner la stratégie d'accès anticipé avec les parties prenantes internes (affaires médicales mondiales et locales, chaîne d'approvisionnement, distribution, juridique, accès au marché, réglementation, pharmacovigilance, éthique, commercial...).
- Conformément à la stratégie d'accès anticipé approuvée par produit/indication, participer à la conception des aspects opérationnels de l'accès anticipé.
- Développer par produit/indication la documentation de l'EA (par exemple, le formulaire d'accès du patient, le formulaire de commande, le formulaire de consentement éclairé, les responsabilités du personnel soignant).
- Du début à la fin de l'accès anticipé, gérer les activités transversales avec les différents départements. Fournir une mise à jour mensuelle du statut et de la performance dans le système de gestion électronique des documents (eDMS).
- S'assurer que l'eDMS est toujours à jour en téléchargeant/complétant toute documentation/information fournie par le fournisseur de services, y compris les preuves des documents justificatifs de sécurité.
- Effectuer régulièrement des examens de la qualité dans le SGED.
- S'assurer que la documentation/les informations sont complètes avant de clôturer la demande d'accès au produit (programme d'accès anticipé et autres types d'accès).
- Participer avec le directeur de l'accès anticipé à la formation des employés sur le processus de demande d'accès aux produits.
- Participer à l'amélioration continue du processus et de la documentation.
- Communiquer en interne sur l'avancement des projets (newsletters, infographies, etc.)

Vous avez un diplôme Bac +5 en biologie ou science du vivant. Vous justifiez d’une expérience de 5 ans sur un poste en coordination de projet en recherche clinique au sein de l’industrie pharmaceutique. Vous parlez couramment anglais et avez une expérience réussie dans le management d’équipe. #1314862



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