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.
Bachelor’s Degree required, preferably in physical science, math, engineering or pharmacy. 3 years total experience in Pharmaceucal industry preferred, but not required. Must have experience in one of the following areas: Drug Discovery (e.g. Process Chemistry, Analycal Chemistry), Drug Development (e.g. formulaon), Clinical Operaons (e.g. Clinical Project Management), Supply Chain (e.g. Clinical Supplies Project Management), Quality Assurance. Proficient in the applicaon of standard business requirements (for example SOPs, Global Regulaons, OEC,). Must have understanding of importance of compliance in a regulated environment and be capable of applying this knowledge to improve current processes. Capable of represenng CDSM as parcipant in and contributor to cross funconal iniaves. Ability to work collaboravely across departments/funcons and interact in a tacul, professional and effecve manner. Ability to manage and priorize mulple tasks under ght deadlines and high pressure. Strong problem solving and Project Management skills. Strong communicaon skills (both wrien and oral).
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
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