Project Manager, Clinical Supply

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Forecasts, plans, schedules, coordinates and executes, ensuring timely availability of investigational drug supplies and related services to clinical sites and depots for clinical supply chain activities. This position is the entry-level position for the GDSM Project Management function. Works on the less complex clinical studies and will require significant guidance through the learning curve process. 

Responsibilities

• Maintains and adheres to applicable Corporate and Divisional Policies and procedures. Represents CDSM activities as a member of the Clinical Study Team.
• With guidance, provides input to Clinical Study Teams to influence clinical protocol design to ensure most efficient utilization of supply chain resources. Translates clinical study design into packaging design.
• Develops protocol specific labeling compliant with applicable global regulations. Identifies, develops, communicates and tracks project timelines, activities, logistics, and milestones.
• Responsible for creating appropriate protocol specific manufacturing and packaging work orders in concert with QA, GPAS, and clinical team partners, ensuring timely availability of clinical supplies. Forecasts and coordinates the execution of required packaging jobs including retest expiry label updates.
• Participates in CDSM Knowledge Management Meetings and presents relevant topics on an ad hoc basis. Proactively provides input on process improvement opportunities.
• Successfully participates in Process Improvement initiatives. Partners with Clinical Statistics and CDSM Coordination staff to prepare appropriate protocol specific randomization code files and blind breaker envelopes, as required.
• Coordinates with CDSM Materials Management to establish study specific distribution plans for shipment of packaged supplies. Manages inventory of finished goods and ancillary supply through study completion. Tracks retest dates and subsequent dating extensions of study medication.
• With mentoring, participates in troubleshooting and resolving clinical supply related issues ensuring that project needs and priorities are understood by key team members. Effectively utilizes MS Project to manage key project activities.
• With guidance, may be responsible for project management of IVRS/IWRS activities. Provides input and recommendation to CSPMs / DSMs on project timing, resource requirements, and budget projections.

Qualifications

• Bachelor’s degree in the Life or Physical Sciences preferred. Will consider Business Administration, Math or Engineering with appropriate work experience.
• 1 year of project management experience or 3+ total years of Pharmaceutical or Biotechnology industry or equivalent experience preferred.
• Must have excellent problem solving and logical reasoning skills.
• Proactive approach to problem solving, thinking outside of the box, and ability to identify creative solutions to unique problems.
• Possesses the ability to think and act with regard to multiple functions with exceptional follow-up skills.
• Proficient with standard computer software. Must be able to effectively manage multiple projects at one time.
• Strong Project Management skills.
• Strong communication skills (both written and oral). Ability to work independently or with a group.

Additional Information

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 ma