CTSU Packaging & Labeling Expert (m/f/d)
Your responsibilities
- 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 Team
- Global 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.
Your profile
- Master degree in Informatics, Business Informatics, Bioinformatics or similar, possibly combined with a bachelor degree in science (Biology, Chemistry, Biochemistry, etc.) with profound work experience
- You should have profound specific experience in an industry environment, preferably pharmaceutical or biotech
- Profound knowledge of laboratory and manufacturing data systems in a regulated or R+D environment
- Biotechnology or Bioinformatics background or comparable is preferred
- Good understanding of the impact of standardization procedures and processes in a data driven environment.
- Master Data Management experience is a plus
- Experience in leading change and role modeling values
- Open and communicative personality to deal with the high number of different interfaces
- Ability to deliver on target and maintain a business process in high quality and sustainability.
- Business fluent in German and English
Your benefits
- Working in an international company
About Hays
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.
Staffing process for a permanent or temporary position
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We will review your application documents and carry out a detailed analysis of your professional qualification.
Your contact at Hays
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