Time for change – time for a new job! You are a regulatory and ethics committee submission coordinator and looking for a new professional challenge? Then stop searching! We offer the job you are looking for: Our subsidiary GULP solution services offers a secure job, fair compensation and exciting new tasks at an attractive pharmaceutical company in Penzberg. Apply online now! We welcome applications from all suitably qualified persons regardless of any disabilities.
Das dürfen Sie erwarten
* Attractive salary and long-term job security through affiliation with the Group
* Up to 30 days vacation per year
* Contribution to company pension scheme after end of probationary period
* Extensive social benefits, including Christmas and vacation bonuses
* Compensation for travel expenses
* Usually a permanent employment contract
* Good chances of being taken on by our business partners
* Targeted training opportunities and free language courses
* A wide range of discounts for employees
Ihre Aufgaben
* Prepare application forms for submissions to regulatory authority and if applicable, ethics committees for analytical performance studies under IVDR
* Review and adapt documents and templates relevant for submission
* Compile submission packages
* Submit the applications for approval of a performance study under IVDR via the DMIDS and later the EUDAMED system
* First point of contact for queries from the Ethics Committee and the authority
* Prepare and submit the answers to queries
* Oversight of CRO/CRA activities
Unsere Anforderungen
* Bachelor or Masters Degree in Life Sciences (Ph.D. would be ok)
* Solid professional experience as CRA, Study Manager, Clinical Associate, Regulatory in the Diagnostics Industry
* Knowledge in IVDR and MPDG
* Fluent in English and German for the communication with German authorities