Clinical QC Compliance Associate II

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

• Conducts independent quality control reviews of regulatory, scientific, and clinical documents with applicable checklists by checking against sources to ensure that the results presented are accurate and delivers documented quality control review comments to the author through resolution.
• Ensures quality control review documentation is completed from all areas and provided/uploaded to the applicable master file(s) per the established business processes and procedures.
• Interacts daily with ClinPharm writers and/or ClinPharm writing managers and interfaces/communicates with applicable cross-functional areas. Communicates and provides deliverables to ClinPharm writers, ClinPharm writing managers, and others as applicable.
• Accountable for receiving and meeting the main objectives/deliverables of the assigned tasks, roles, and responsibilities within established timelines with high quality, consistency, and accuracy.
• Support the project activities to ensure Clinical Pharmacology compliance with regulatory and corporate standards, including quality updates to standard documents and process enhancements across all Clinical Pharmacology.
• Expediently escalating issues to management is essential and may directly impact the ability to meet project deliverables/timelines.
• Maintains strong knowledge of clinical and regulatory documents requiring quality control review and business processes and procedures for these documents.
• Provide valuable Quality Control and compliance support for internal audits and regulatory authority inspections of Clinical Pharmacology and ACPRU.

Qualifications

* Position is required to be on-site 3-4 days a week*

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