Quality Control Associate II
USA, Illinois, Lake County
1 additional location
Must be familiar with ICH and GCP Guidelines.
Must demonstrate good interpersonal and organizational communication skills.
Determines scope of QC review with the document author and the source documents and/or data required (in addition to utilizing any applicable checklist).
Conducts independent quality review of documents by checking against source (documents and/or data) to ensure that the results presented are accurate (emphasis on checking the numbers/data in the text and in-text tables against the final statistical tables, listings, and graphs (TLGs). Deliver documented quality review comments/checklist to document author through resolution.
Ensures QC review documentation from all applicable functional areas is completed and provided to Document Management for the TMF per the established business processes and procedures.
Maintains strong knowledge of clinical regulatory documents requiring QC as well as business processes and procedures for these documents. Demonstrates strong attention to detail and a high level of quality, consistency, and accuracy in work effort.
Daily interaction with Medical Writers and/or Medical Writing managers as well as interface/communication with applicable cross-functional areas. Communicates and provides deliverables to Medical Writers, Medical Writing managers, and others as applicable
Mentors and provides guidance/training to less senior Medical Writing staff or others as applicable. Back-up to individual maintaining overall QC schedule and the assignment of QC review of clinical regulatory documents.
Accountable for meeting the main objectives of the assigned projects/roles and responsibilities within established timelines and with an appropriate quality level. Drives the QC of clinical regulatory documents to timely completion.
Accountable to Senior Manager, Medical Writing. Exhibits a moderate level of technical competencies and requires a low level of counsel and guidance. Expedient escalation of issues to management is essential and may have a direct impact on the ability to meet project timelines.
Bachelor's degree (BA/BS) required.
2-4 years relevant pharmaceutical industry experience in medical writing, clinical research, quality, or related area such as regulatory or product support.
Experience in quality review of clinical regulatory documents.
Experience in being flexible with changing workload that requires prioritization and planning to support immediate/urgent business needs.
Proficient experience in use of MS Office (e.g., Word, Excel, Outlook, PowerPoint) and Adobe Acrobat. Experience/familiarity with SharePoint, ISIPublisher, and eDocs (i.e. electronic document management system) desirable.
Project management experience desired.
AbbVie is an Equal Employment Opportunity employer: 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.
Significant Work Activities and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced