A clinical stage biopharmaceutical company is looking for an experienced Clinical Supply Manager to join their team in Vienna. The organisation is currently developing a new clinical supply team and are looking for someone to be the link between the US and EU and build a strong team around them.
Provides strategic direction for clinical supply chain planning activities for clinical trial studies Actively participates in project team meetings to work with cross functional teams including Technical Development, Clinical Operations, Regulatory Affairs, and Quality Management to provide feedback from a clinical supply chain perspective. Provide oversight to CMOs for labelling and packaging, drug depot service, transportation logistics, IMP relabelling coordination. Develops the program level demand planning forecasts and budgets based on the book of work for clinical drug supplies through all phases of clinical development for assigned programs Monitors ongoing study level activity to ensure sufficient supply. Manage inventory targets and safety stock levels. Develop a labelling strategy that meets regulatory and study requirements. Lead the development and approval of label text and label proofs including country-specific translations.
Skills and Requirements
Bachelor's Degree in Life Sciences, Business, Engineering, Supply Chain Management or related field. MSc/MBA is desirable. 2+ years' experience in production planning and inventory control in the bio/pharmaceutical industry. Experience with working with biological safety product(s) 1 and/or 2 is preferred. Proficiency with Excel modeling or other supply planning systems. General knowledge of current GMP/GCP/GDP regulations. Experience in a highly matrix environment with demonstrated leadership. Collaborative team player with strong interpersonal skills and ability to drive team actions and results. English as a native language or other nationality with top quartile English capabilities (reading and writing)
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A full job description is available on request.