Informationen zur Anzeige:
Label Development Specialist*in 5363EUR plus Prämien
apero GmbH
Biberach an der Riß (DE)
Aktualität: 08.12.2024
Anzeigeninhalt:
08.12.2024, apero GmbH
Biberach an der Riß (DE)
Label Development Specialist*in 5363EUR plus Prämien
Aufgaben:
- Autonomously review of Master Label Text drafts 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 teams, Regulatory Affairs, Global Randomization, Medicine and label vendors to create, define and optimize labeling related tasks
- Hold PLC internal and external team and pack & label vendors 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 Specialist 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 external vendors. PLC-L Specialist acts as main contact for vendors and countries
- Contact person for all upcoming questions during the label process
Qualifikationen:
- Master's Degree with several years of experience in a related field or professional training with extensive experience in a related field
- Background in Clinical Trials (Supply Chain, Clinical Trial Regulations, Packaging and Labeling area, medical documentation)
- Experience with labeling needs & processes, i.e. Food industry
- Demonstrates knowledge of all areas of clinical supply chain activities and a thorough knowledge and understanding of applicable regulations (e.g. CTR 536/2014)
- Solid project management skills
- Ability to interpret standard and complex project requirements
- Strong problem-solving, risk assessment and troubleshooting skills
- Work independently and in a global team environment
- Strong computer skills (e.g. Microsoft Office)
- Fluency in English
Wir bieten:
- Persönliche Betreuung und kompetente Ansprechpartner
- Übertarifliche Vergütung
- Pünktliche Auszahlung des Lohns
- i.d.R. unbefristete Arbeitsverträge
- Bis zu 30 Tage Urlaub
- Urlaubs- und Weihnachtsgeld
- Individuelle Schulungen/Qualifikation/Weiterbildungen
- Kostenübernahme bei arbeitsmedizinischen Vorsorgeuntersuchungen
Unser Kontakt:
Kontaktdaten für Stellenanzeige
Apero GmbH
Frau Poser
Personaldisponentin
Marktplatz 1
88400 Biberach an der Riß
Deutschland
Telefonnummer: +49 (73 51) 82 98 63 20
Faxnummer: +49 (73 51) 82 98 63 36
E-Mail: jobs@apero.de
Art(en) des Personalbedarfs: Neubesetzung
Tarifvertrag: GVP-DGB (100% nach IG Chemie)
Entgeltgruppe: E12T
Standorte
Label Development Specialist*in 5363EUR plus Prämien
Drucken
apero GmbH
Biberach an der Riß (DE)
