Friederike Walther

• Perform secretarial duties which include typing correspondence and other administrative documents and reports related to clinical studies • Collection, tracking, verification and appropriate dissemination/distribution of essential and other documents • Organisation of all translations in local language, when required, of all study related documents • Track and keep records of patient enrollment • Order, receive and dispatch to investigators study drug supply. Coordinate return and destruction of unuse

Mein Aufgabengebiet ist sehr vielseitig und ich betreue mehrere Projekte innerhalb der Produktion und Konfektionierung der Arzneimittel (Konfektionierungsanweisungen, Herstellungsanweisungen, Prüfung von Stücklisten und Produktanforderungen, Teilnahme an Besprechungen und Erstellung von Besprechungsprotokollen, CAPA-Maßnahmen sowie Change Control Bearbeitungen). Darüber hinaus verwalte ich die Abtei

• Assisting in the management of international clinical trials in line with trial specific requirements (protocol, SOPs) and regulations (national drug laws, guidelines, etc.) • Communication with sponsor representatives, regulatory health authorities, competent ethics committees and project team • Preparation of the documentation with respect to project related SOPs (spon-sor and IFE) • Attendance to periodic project meetings and preparartion of meeting minutes for the communication of project status wi

• Assisting in the management of international clinical trials in line with trial specific requirements (protocol, SOPs) and regulations (national drug laws, guidelines, etc.) • Communication with sponsor representatives, regulatory health authorities, competent ethics committees and project team • Preparation of the documentation with respect to project related SOPs (spon-sor and IFE) • Attendance to periodic project meetings and preparartion of meeting minutes for the communication of project status with

Fachrichtung Philosophie