Provides input to Clinical Study Teams to influence clinical protocol design to ensure most efficient ulizaon of supply chain resources. Translates clinical study design into packaging design. Authors the study medicaon and labeling secon of the clinical protocol. Develops protocol specific labeling compliant with applicable global regulaons. Idenfies, develops, communicates and tracks project melines, acvies, logiscs and milestones. Responsible for creang appropriate protocol specific manufacturing and packaging work orders in concert with Third Party and IRT vendors, quality assurance, clinical team partners, etc. to ensure mely availability of clinical supplies. Responsible for protocol specific clinical supplies scenario analysis, risk management and conngency planning. Forecasts protocol specific bulk drug product requirements, including comparator agents, ancillary supplies and commodies, including overages. Parcipates in cross funconal iniaves as drug subject maer expert. Leads in funcon improvement iniaves.
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