CTSU Packaging

Autonomously review, check and approval of Master Label Text draft considering regulatory requirements,standard text phrases and trial specifics.Autonomously prepare country specific label text for translation of attending countries.Autonomously review and check translated label text considering local requirements.Autonomously review and check generated print proofs and distribute proofs to countries for check and approval.Autonomously work in conjunction with CTSU Trial team, Regulatory Affairs, Global Randomization, Medicine and label vendors to create, define and optimize labeling related tasks.Hold PLC internal and external Team at BI and pack & label vendor responsible for keeping their timeline and providing overview on the IMP pack & label milestones to the global CTSU trial team as well as ensures appropriate and effective communication to all functions.Compile and provide completed label documentation for final release to the Release and Process Management TeamGlobal PLC-L Expert provides all relevant Documents like Master Label Text, Country List, Packaging Design, STORM Document and all other country and product specific information necessary to perform this task by pack & label vendor. PLC-L Specialist acts as main contact for vendors and countries.Contact person for all upcoming questions during the label process. Master degree in Informatics, Business Informatics, Bioinformatics or similar, possibly combined with a bachelor degree in science (Biology, Chemistry, Biochemistry, etc.) with profound work experienceYou should have profound specific experience in an industry environment, preferably pharmaceutical or biotechProfound knowledge of laboratory and manufacturing data systems in a regulated or R+D environmentBiotechnology or Bioinformatics background or comparable is preferredGood understanding of the impact of standardization procedures and processes in a data driven environment. Master Data Management experience is a plusExperience in leading change and role modeling valuesOpen and communicative personality to deal with the high number of different interfacesAbility to deliver on target and maintain a business process in high quality and sustainability. Business fluent in German and English Working in an international company With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.