results in internal and external meetings Supervise and mentor a team of statisticians Lead the development of the SAP(s) for interim and final reports Safeguard adequate resource planning and adherence to
Programmiersprache in Anlehnung an BASIC), zur Unterstützung und Protokollierung des Herstellungsprozesses Erstellung von Reports (Report Builder) zur Visualisierung von Daten des MES Betreuung von System-Release
Responsible for coordinating the tracking and distribution of adverse event reports associated with investigational and marketed products Booking adverse events in the safety database Maintaining
actions in collaboration with the Quality Manager Quality review of deviation reports and corresponding corrective actions, change control reports, and SOPs Maintenance and update of electronic databases
maintenance, experimental design, Data acquisition, data documentation and interpretation, issue resolution, compliance with GLP/GCP regulations, preparation of draft bioanalytical reports and method
und ordnungsgemässe und vollständige Dokumentation in Batch Manufacturing Records (BMRs) gemäss cGMP Dokumentation der gewonnenen Erkenntnisse in Reports, Registrierungsdokumenten und Patenten Mitglied
out of specification(OOS), training, change management, complaints) including practical development, testing, implementation, documentation Author protocols, rationales and reports Support Change
Write and review clinical regulatory documents such as clinical study reports, investigator’s brochures and CTD Module II summaries Collaborate with Regulatory Project Managers, Clinical Science
biometrician in the study-implementing teams of the clients Creating analysis plans Carrying out and / or monitoring the analyzes Cooperation in the report preparation Development of programs for the
including, but not limited to STAR maintenance, ISMP maintenance, and drug safety reports Contributing to risk management activities including preparation and maintenance of CCDS, labeling document
expenses, processing expense reports (e.g. travel) and billing from consultants Participation in various Global Drug Safety projects and programs in collaboration with other team members Provide support to
Lead and/or contribute to the development of the clinical study database and all components in collaboration with the Study Data Manager, who provides the core specifications Development of reports
health authorities Fundamental understanding of standard device/packaging analytical testing Expert in reviewing and writing technical reports Knowledge regarding design control, documentation, risk