About AbbVie
AbbVies 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 peoples lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, womens 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.
Major Job Responsibilities
* Responsible for the project management of key Clinical Supply Chain activities at the protocol level for Phase 1, 2, 3, 4 and IIS studies of increasing complexity
* Includes forecasting, planning, scheduling, coordination and execution, ensuring timely availability of investigational drug supplies and related services to clinical sites and depots.
* 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. Authors the study medication and labeling section of the clinical protocol.
* 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 Third Party and IVRS vendors, QA, clinical team partners etc to ensure timely availability of clinical supplies.
* Responsible for protocol specific clinical supplies scenario analysis, risk management and contingency planning. Forecasts protocol specific bulk drug product requirements, including comparator agents, ancillary supplies and commodities, including overages
Qualifications
Qualifications
Education/ Experience
* Bachelors Degree required, preferably in physical science, math, engineering, or pharmacy
* 5- 8 years total experience in the Pharmaceutical Industry
* Grade level commensurate with education and experience.
* Key Leadership Competencies:
* Builds strong relationships with peers and cross functionally with partners outside of the immediate 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 to drive the science in the field of interest
* 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)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
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.
Chicago, IL
AbbVie Inc. discovers, develops, manufactures, and sells pharmaceutical products in the United States, Japan, Germany, Canada, Italy, Spain, the Netherlands, the United Kingdom, Brazil, and internationally. The company offers HUMIRA, a therapy administered as an injection for autoimmune and intestinal Behçet's diseases; IMBRUVICA to treat adult patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma, waldenström’s macroglobulinemia, marginal zone lymphoma, and chronic graft versus host disease; VENCLEXTA, a BCL-2 inhibitor used to treat adults with CLL or SLL; VIEKIRA PAK, an interferon-free therapy to treat adults with genotype 1 chronic hepatitis C virus (HCV); TECHNIVIE to treat adults with genotype 4 HCV infection; and MAVYRET to treat patients with chronic HCV genotype 1-6 infection.
It also provides KALETRA, an anti-human immunodeficiency virus (HIV)-1 medicine used with other anti-HIV-1 medications to maintain viral suppression in HIV-1 patients; NORVIR, a protease inhibitor indicated in combination with other antiretroviral agents to treat HIV-1; and SYNAGIS to prevent respiratory syncytial virus infection at-risk infants. In addition, the company offers AndroGel, a testosterone replacement therapy for males; CREON, a pancreatic enzyme therapy for exocrine pancreatic insufficiency; Synthroid to treat hypothyroidism; and Lupron to treat prostate cancer, endometriosis, and central precocious puberty, as well as anemia.
Further, it provides Duopa and Duodopa, a levodopa-carbidopa intestinal gel to treat Parkinson’s disease; Sevoflurane, an anesthesia product; and ORILISSA, a non-peptide small molecule gonadotropin-releasing hormone antagonist for women with moderate to severe endometriosis pain. It has collaborations with Alector, Inc.; Janssen Biotech, Inc.; Galapagos; Bristol-Myers Squibb Company; and Calico Life Sciences LLC. The company was incorporated in 2012 and is headquartered in North Chicago, Illinois.