Manager/ Clinical Disclosure Office

Manager/ Clinical Disclosure Office
Empresa:

Innovative Medicines


Detalles de la oferta

.SummaryManager, Clinical Disclosure Office, Location: Barcelona, Spain or London, UK #LI-HybridThe Manager, Clinical Disclosure Office ensures quality and compliant protocol registrations and results postings as well as alignment with global registries (i.E.ClinicalTrials.Gov, EudraCT, EUCTIS, Novartis Clinical Trial Results EMA-HMA Catalogue of non-interventional studies etc.) with oversight.They are also accountable for protocol registry and results eligibility assessment and must demonstrate capability to interpret, discuss and ensure appropriate trial data is accurately represented in clinical registries.About the RoleKey Responsibilities:Participate in client trainings within Biomedical Research and Novartis Pharmaceuticals to drive quality and compliance and organizational alignment to changing disclosure requirements.Responsible for staying current with global policies & regulations and operational application to ensure harmonization of Novartis transparency processes and standardsIndependently represent Novartis to internal stakeholders. Develop and maintain effective working relationships with global and country multidisciplinary leaders, such as Study Leads, M.D.S, Legal, and Business Development & Licensing.Participate in the maintenance of Standard Operating Procedures and preparations for external & internal audits.Apply a continuous improvement mind set ensuring best practices are shared continually driving to the most productive processesEssential RequirementsBachelor's degree in a scientific discipline preferred.Minimum 3 years pharmaceutical industry experience with knowledge in disclosure including registration, maintenance, and results disclosure. (Experience with ClinicalTrials.Gov, EudraCT and the Citeline Disclose tool (also known as PharmaCM) advantageous)knowledge of drug development, experience in writing protocols, experience in multiple clinical indications and/or therapy areas desiredProven development skills in a responsible position within Clinical Research & Development, Data Management, Project Management, Medical Writing, Regulatory Affairs or related areasAbility to successfully work within complex cross divisional matrix; previous experience leading multidisciplinary teams in matrix environmentStrong negotiation & conflict resolution skills; well organized, focusedon results/compliance, strong planning, tracking, problem solving and decision making skillsProficiency in Good Clinical Practice, Regulatory Processes and clinical trial de signsAbility to adapt to changing external environmentWhy Novartis?Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions


Fuente: Jobtome_Ppc

Requisitos

Manager/ Clinical Disclosure Office
Empresa:

Innovative Medicines


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