Associate, Quality Control Ii

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 Twitter, Facebook, Instagram, YouTube and LinkedIn.

Responsible for ensuring the quality of clinical regulatory submission documents authored primarily by medical writing by conducting Quality Control review utilizing checklists as well as ensuring that the Quality Control review documentation is provided to the applicable master file(s) per the established business processes and procedures. Key contributor in process and operational improvement activities. Subject Matter Expert (SME) on master file content management system (Veeva Vault). SME for audit/inspection readiness/requests.

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  Determines scope of Quality Control review with the author and the source documents and/or data required. Conducts independent Quality Control review of documents with applicable checklist by checking against source 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 Control review comments/checklist to 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.
• Maintains strong knowledge of clinical regulatory documents requiring Quality Control review and business processes and procedures for these documents.
• Interacts daily with medical writers and/or medical writing managers and interfaces/communicates with applicable cross-functional areas. Communicates and provides deliverables to medical writers, medical writing managers, and others as applicable.
• Assists in the management and oversight of the Quality Control Mailbox. Track and maintain metrics associated with quality audit/control. Assist in the preparation and maintenance of internal process documents and training materials related to quality audits/control deliverables.
• Acts as back-up to individual maintaining overall Quality Control schedule and the assignment of Quality Control review of clinical regulatory documents.
• Accountable for meeting the main objectives/deliverables of the assigned projects/roles and responsibilities within established timelines with a high level of quality, consistency, and accuracy.
• Able to expediently escalate issues to management is essential and may have a direct impact on the ability to meet project deliverables/timelines.
• Participates and is a key contributor in process and operational improvement activities (e.g., CeSaR BOT for automation of Quality Control scheduling/tasks). Acts as subject matter expert on master file content management system.
• Acts as Quality Control business subject matter expert for medical writers and others in support of the increased importance/focus on Quality Control and business processes across the organization for audit/inspection readiness/requests.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs.
  

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.