Zielführend und persönlich - Ihre Entwicklungschancen sind einmalig.
- Providing the supply of clinical trials with pharmaceutical products according valid laws, GMP-formalities and quality-standards in agreed timelines and cost efficiency requirements for global phase I - IV clinical programs
- Study specific contact person for all packaging & labeling activities within internal packaging area for assigned projects and trials within trial team
- Ensures the timely provision of packaging related tasks of clinical supplies for assigned trials
- Packaging Labeling Coordination (PLC) in alignement with the trial team provides packaging related supply chain tasks and is primary contact of the packaging operation areas (internal)
- Creation and check of master batch records and packaging orders (including review)
- Providing of packaging & labeling documents for final release. Development and optimization of processes for packaging clinical trial supplies
- Ensure that all work is performed in a safe manner and in conformance with US, EU, German and other international regulations
- Accountability for a broad set of activities to enable and support numerous functions in Global CTSU including the maintenance of a number of interface relationships to ensure the efficiency of the CTSU/ PLC responsibilities. The accountabilities require thorough planning as well as quick decision making in complex situations
Fachlich und persönlich - Ihre Qualifikation ist überzeugend.
- Masters degree or equivalent in relevant scientific area or alternatively Bachelors degree or equivalent in relevant scientific area plus relevant experience
- Proven customer orientation across functions including sense of urgency and priority Project management capabilities and experience
- Capability for fast and focused decision making, including risk assessments, to deliver results, while driving for innovation and improvement
- Ability to interpret complex project requirements, associated regulations and highly complex experimental data to drive results in a changing environment
- Driver of implementation for new systems, innovations, methods and working concepts to increase standardization and efficiency in PLC related tasks
Unser Angebot ist für Sie genau die richtige Entscheidung? Dann bewerben Sie sich direkt online oder per E-Mail unter der Kennziffer JU68-32279-UL bei Frau Marisa Grauer. Denn was für unsere Kunden gilt, gilt für Sie schon lange: Wir entwickeln Sie weiter.