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Associate Director, Data Standards

AbbVie · North Chicago, Illinois, US

Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and ad...

Job description

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: Lead, manage and develop a group of data standards experts to develop, implement and maintain end-to-end data standards from data collection to regulatory submission. Govern change control, publication and communication of new and updated data standards. Responsibilities: Ensure any unresolved issues are appropriately documented (for example in the FDA's Data Reviewer's Guides)" - Responsible for compliance with applicable Corporate and Divisional Polices and procedures - Industry Standards - Maintains complete and in-depth understanding of all CDISC guidance documents and implementation guides as well as FDA guidance and regulatio...