Clinical QC Compliance Associate II

• 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*

• Bachelors degree in a science-related field with 2-3 years of Pharmaceutical industry experience in quality control/review of clinical regulatory documents or related experience in an area such as quality assurance clinical research drug development medical writing regulatory or product support/R&D.   
• Working knowledge of global regulatory requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions. Competent/expertise in the application of business processes (guidelines standard operating procedures work instructions job aids etc.).
• Knowledge of clinical study principles with experience supporting clinical research drug development and/or therapeutic area operations.
• Experience in being flexible with changing workload that requires prioritization and planning to support immediate/urgent business needs.
• Excellent oral/written communication interpersonal/organizational analytical/critical thinking and conflict management skills. Superior attention to detail and ability to appropriately and effectively use resources to prioritize multiple tasks/projects.
• Proficient skills and knowledge in Microsoft Office products (Word Excel OneNote Outlook PowerPoint) in the Windows operating system environment are required.
• Preferred experience with content management and archival systems for eTMF (Cosmos Vault One-Vault).

Additional Information :

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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

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