Expanded Access Manager – Post-Trial Access Specialist

🔥 il y a 3 heures

🇬🇧 Royaume-Uni – Télétravail

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👔 Manager

👻 Score fantôme 10%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

Postuler Maintenant

Trouver des Emplois à Distance Similaires

Configurer une alerte email pour les nouveaux emplois

📊 Vérifiez votre score de CV pour ce poste

Améliorez vos chances d'obtenir un entretien en vérifiant votre score de CV avant de postuler.

Télécharger le CV

Thermo Fisher Scientific

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1956

🏥 Santé

📦 Logistique

🏭 Fabrication

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific est le leader mondial dans le service aux sciences, avec un chiffre d'affaires annuel de plus de 40 milliards de dollars. Leur mission est de permettre à leurs clients de rendre le monde plus sain, plus propre et plus sûr en soutenant la recherche en sciences de la vie, en résolvant des défis analytiques complexes, en augmentant la productivité des laboratoires et en améliorant la santé des patients grâce aux diagnostics et au développement de thérapies révolutionnaires. Avec une équipe mondiale, ils offrent des technologies innovantes et des services pharmaceutiques à travers des marques telles que Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon et PPD.

Description

• Set up and manage operational support for post-trial managed access programs from planning through close-out • Coordinate budgets, clinical trial management systems, vendor communications, investigational product stock and delivery, documents, agreements, contracts and correspondence • Collaborate with clinical study teams to assess feasibility, regulatory requirements, logistics and supply mechanisms • Partner with global and local medical affairs, clinical operations and cross-functional stakeholders • Coordinate day-to-day support to maintain continuity of access for post-trial patients • Track program status, investigational product management, documents and data review activities in line with regulatory requirements and Good Manufacturing Practice • Manage vendors supporting program execution • Coordinate expanded access activities, including document collection, filing, archiving, timelines and metrics • Provide program status and utilization updates to stakeholders • Support clinical supply planning and forecasting with CMC and other functional areas • Develop project materials and operational communication tools • Identify delivery issues and risks, coordinate corrective actions and communicate with stakeholders • Track milestones and timelines and contribute to program initiatives and process improvements

🎯 Exigences

• Bachelor’s degree in a scientific or clinical discipline, or equivalent relevant education and experience • At least 3 years of relevant experience in the pharmaceutical, biotechnology, clinical research or CRO industry • Direct experience in clinical research or managed access, for example as a study manager, Clinical Research Associate (CRA), project manager or in a comparable role • Working knowledge of compassionate use, early access or expanded access programs • Proven ability to work effectively in cross-functional teams • High level of integrity, accuracy and attention to detail • Strong organizational, prioritization and project management skills • Ability to deliver assignments on time and within budget • Strong problem-solving skills and sound judgment • Excellent written and verbal communication skills • Understanding of cross-functional responsibilities across Supply Chain, Regulatory, Pharmacovigilance, Legal, Medical Writing and local medical teams • Ability to coordinate multiple workstreams, stakeholders, vendors and deliverables • Ability to interpret operational and regulatory requirements and translate them into practical program plans • Ability to communicate risks, status, timelines and actions clearly to internal and external stakeholders • Commitment to quality, compliance and continuous improvement

🏖️ Avantages

• Full-time employment • Fully remote work arrangement • Standard Monday–Friday work schedule