AbbVie Senior Project Manager, Clinical Supply responsible for clinical supply chain planning and execution to support clinical study protocols. Manages labeling, manufacturing work orders, and risk management for clinical supplies.
Responsibilities
Provide input to clinical study teams for protocol design to optimize supply chain resources
Translate clinical study design into packaging design
Author medication and labeling sections of clinical protocols
Develop protocol-specific labeling compliant with global regulations
Create manufacturing and packaging work orders with vendors and partners
Conduct scenario analysis, risk management, and contingency planning for clinical supplies
Forecast bulk drug product requirements including comparator agents and ancillary supplies
Participate in cross-functional initiatives as drug subject matter expert
Lead functional improvement initiatives
Qualification
Bachelor’s DegreeExperience in one of the following
Required
Bachelor’s Degree, preferably in physical science, math, engineering or pharmacy
3 years total experience in pharmaceutical industry preferred
Experience in one of the following: Drug Discovery, Drug Development, Clinical Operations, Supply Chain, Quality Assurance
Proficient in application of standard business requirements (SOPs, Global Regulations, OEC)
Understanding of compliance in regulated environment
Ability to work collaboratively across departments
Strong problem solving and project management skills
