Project Manager, Clinical Supply

North Chicago, IL, United Statesfull timeOn Site

Apply on Employer Site

entry

H1B: yes

AbbVie Project Manager, Clinical Supply at AbbVie responsible for translating clinical study design into packaging design and managing clinical supply logistics. Leads protocol-specific clinical supplies scenario analysis, risk management, and contingency planning.

Responsibilities

Provide input to Clinical Study Teams to influence clinical protocol design
Translate clinical study design into packaging design
Author the study medication and labeling section of the clinical protocol
Develop protocol specific labeling compliant with applicable global regulations
Identify, develop, communicate and track project timelines, activities, logistics and milestones
Create appropriate protocol specific manufacturing and packaging work orders
Ensure timely availability of clinical supplies
Conduct protocol specific clinical supplies scenario analysis, risk management and contingency planning
Forecast protocol specific bulk drug product requirements including comparator agents and ancillary supplies
Participate in cross functional initiatives as drug subject matter expert
Lead in function improvement initiatives

Qualification

Bachelor’s Degree required

Required

Bachelor’s Degree required, preferably in physical science, math, engineering or pharmacy
3 years total experience in Pharmaceutical industry preferred but not required
Experience in one of the following areas: 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 a regulated environment
Ability to work collaboratively across departments/functions
Ability to manage and prioritize multiple tasks under tight deadlines
Strong problem solving and Project Management skills
Strong communication skills (written and oral)