Für unseren Klienten, ein global agierendes Pharma-/Biotechunternehmen mit Standort in Biberach suchen wir einen:
CTSU Packaging & Labeling Expert (m/w/d)
Stelleninhalte
- The Global CTSU PLC Labeling Expert (PLC-L) is accountable for processing, planning, monitoring and steering of timelines, tasks and costs for labeling activities performed at BI internal or at the packaging & labeling vendor supporting global clinical trials phase I - IV. The Global CTSU PLC Labeling Specialist ensures within the Global CTSU Trial Team the timely provision of all kind of IMP labels for assigned trials by communicating and negotiating all labeling related activities
- 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.
Profil:
- Experience in Pharmaceutical Industry with a focus on Development and Manufacturing activities or ideally on Clinical Trial Supply Chain activities is required, especially in an international environment, and a good understanding of clinical development processes
- Thorough expertise in pharmaceutical packaging and labeling processes, materials and international regulations
- Master's Degree with several years of experiences in a relevant area
- At least 2 years relevant experience in Pharmaceutical industry
- Proven excellent team orientation across international functions including sense of urgency and priority
- Proven ability to interpret complex requirements, associated regulations and highly complex data to drive results in a changing environment
- Capability for fast and focused decision making, including risk assessments, to deliver results, while driving for innovation and improvement
- Excellent written and verbal communication skills. Demonstrated ability to present projects / status reports to different audiences. Fluent in English, spoken and written.
- Broad and thorough knowledge and understanding of applicable US and EU regulations and other international regulations, as well as packaging and labelling processes
- Strong computer skills (e.g. Microsoft Office 365, Project Management Software)
Könnte dies Ihre nächste Herausforderung sein? Ich freue mich auf Ihre Bewerbung!
Thomas Jin
Scientific Talent Acquisition Specialist - Kelly Scientific Resources
089 384 090 7
thomas.jin[at]kellyservices.de
About Kelly
Kelly Services ist Ihr Spezialist für die Vermittlung von Fach- und Führungskräften. Wir bringen Sie mit genau dem Unternehmen zusammen, das zu Ihnen passt. Eine Vermittlung über uns ist persönlich, vertraulich und unkompliziert.
Unser Versprechen
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