Clinical Label Printing Specialist
AbbVie’s mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Clinical Supply Management (CSM) is a part of the Clinical Drug Supply Management (CDSM) organization within R&D Development Sciences. CSM is responsible for the management, planning, packaging, labeling, and distribution of investigational products and clinical trial materials to support all AbbVie Phase I to Phase IV studies, along with Investigator Initiated Studies and Compassionate Use situations.
- Execute label printing using a global IT system ensuring appropriate printing options are chosen in order to obtain optimal print quality.
- Pay meticulous attention to detail when inspecting printed labels for quality and quantity.
- Consistently strive to meet time commitments and optimize operational effectiveness.
- Verify accuracy of the randomization range.
- Print blind-breaker and randomization envelopes for necessary studies.
- Maintain label stock inventory in the label room.
- Receive third party printed labels and prepare labels and associated documentation for inspection
- Support and ensure all work meets cGMP’s relevant procedures and guidelines.
- Stay current on all required training.
- High School Diploma or GED
- Proven ability to work independently and maintain a high level of accuracy when completing all activities.
- Knowledge of clinical trial design and clinical packaging processes preferred.
- Have a solid understanding of cGMP’s and how they pertain to the label generation process for clinical studies.
- Good verbal and written communication skills.
- Must be proficient at multi-tasking, responsible for timelines, provide status updates on an ongoing basis to ensure all work meets cGMP’s procedures.
- Computer proficient.
- Ability to provide quality, detail-oriented work in a changing environment.
Key Leadership Competencies:
- Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
- Learns fast, grasps the "essence" and can change course quickly where indicated.
- Raises the bar and is never satisfied with the status quo.
- Creates a learning environment, open to suggestions and experimentation for improvement.
- Embraces the ideas of others, nurtures innovation and manages innovation to reality.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.