Packaging & Labelling Expert for Clinical Trial Medicines (m/f/d)/Baden-Württemberg (24 months) - Redmond, United States - Omega Enterprises
Description
Responsibilities:
- Coordinating packaging and labeling of clinical trial supplies at contract manufacturers
- Managing and coordinating internal processes
- Effective collaboration with contract manufacturers and internal stakeholders
- Risk assessment and mitigation, as well as process improvement suggestions
- Reviewing manufacturing documentation from contract manufacturers
- Handling deviations at contract manufacturers
- Creating, reviewing, and training on SOPs
- Representing the team in packaging and labeling discussions and ensuring adherence to timelines and budgets within the global CTSU
- Participating in improvement projects within and outside of the CTSU
Skills:
- Master's degree or equivalent qualification in a relevant scientific field with several years of professional experience
- Experience in the pharmaceutical industry with a focus on packaging or clinical trial supply provision
- Good understanding of clinical development processes
- Knowledge of pharmaceutical packaging and labeling processes and international regulations
- Teamwork skills
- Ability to effectively communicate with external business partners
- Knowledge of project management and supply chain management
- Fluent communication in German and English
Location: Baden-Württemberg
Remote: 40%
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