Beschreibung
Hays ist ein weltweit führender Personaldienstleister, der sich auf die Rekrutierung von Spezialisten konzentriert - sowohl für den Projekteinsatz als auch für Festanstellungen und auf Zeit. In Deutschland, Österreich und der Schweiz vertrauen mehr als 600 internationale Topunternehmen auf unsere qualitätsgesicherten Prozesse, wenn Sie Experten suchen.We are looking for a
Study Authorisation Associate (m/f)
Referenz: -en
Beginn: asap
Dauer: 6 MM++
Ort: in Switzerland
Branche: Medizintechnik
Ihre Aufgaben:
- EC submissions
- Identify and collect necessary documents for submission to specific ECs
- Prepare and complete EC application forms, SIS/IC, study synopsis and other documents according to the EC specific requirements and the clients SOP in collaboration with the project team
- Initiate translation of documents by using local translation services, if required
- Compile EC submission packages and forward it to the relevant person
- Act on any inquiries or objections by the EC in collaboration with the project team
- Collaborate with local experts on country-specific issues
- Maintain database on EC and regulatory requirements for selected countries
- Check database for validity continuously
- Contact EC or regulatory authorities to obtain updated information if necessary
- Update the database with information provided by the clients employees
- Provide EC and regulatory information to the clients employees on request
- Liaise with the clients Regulatory Affairs Department
- Participate in Kick-off Meetings
- Undertake other reasonably related duties as may be assigned from time to time
Ihre Qualifikation
- Experience in clinical research
- Medical/science background and/or relevant experience
- Ability to liaise with other departments and project teams across european offices
- Be able to demonstrate an understanding of regionally specific legislation surrounding ethics committees and submissions procedures and practices
- Excellent interpersonal and presentation skills and the ability to interact at all levels
- Be able to demonstrate a thorough understanding of ICH as well as having both pre-clinical and clinical knowledge
- Fluent in German and English
- Cross industry experience is desirable - pharma / biotec / medical devices
- Ability to prioritise work, have excellent attention to detail, demonstrate a pro-active attitude and have previously worked within a team
- Good working knowledge of Microsoft applications especially PowerPoint
Skills:
- Regulatory Affairs Manager
- CRA
Keywords: Ethikkommission Ethik-Kommisssion Ethical committee Studienantrag klinische Forschung