... cross-functional input into the submission and negotiation strategy by working ... ensure robust and timely HTA submissions to HTA bodies, primarily in ... and value stories, and considering regulatory and label implications. This role ...
Program Coordinator (m w d)Für unser ...
... Management team working with Project Coordinators and Clinical Trial Managers in ... quality control of our internal regulatory filing system Provide oversight and ... disciplined approach. We leverage local regulatory and therapeutic expertise across all ...
... Management team working with Project Coordinators and Clinical Trial Managers in ... quality control of our internal regulatory filing system Provide oversight and ... disciplined approach. We leverage local regulatory and therapeutic expertise across all ...
... drug design strategy. Contribute to regulatory submission of DMPK documents such as ... modelling. Experience answering questions from regulatory authorities. Broad DMPK experience across ...
... approval, as well as preparing regulatory submissions Balancing sponsor generated queries Taking ...
... materials and equipment Ø Assist in submission of proper application documents to EC IRB and, where appropriate to Regulatory Authorities Ø Interfaces with Investigators, external ...
... approval, as well as preparing regulatory submissions Balancing sponsor generated queries Taking ...
... materials and equipment Ø Assist in submission of proper application documents to EC IRB and, where appropriate to Regulatory Authorities Ø Interfaces with Investigators, external ...
... , in particular investigators, study trial coordinators and other site staff; and ... including ICH GCP and local regulatory requirements. Solid communication and computer ...