Clinical Compliance Specialist III
6 days ago
As a Clinical QC Compliance Associate III at AbbVie, you will be responsible for ensuring compliance with corporate and divisional policies and procedures. This role involves performing quality control reviews of regulatory, scientific, and clinical documents for Clinical Pharmacology. You will also be responsible for receiving and completing tasks and assignments from scientific teams and completing them within a time limit with minimal supervision. Additionally, you will lead 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. Your expertise will be valuable in identifying issues that potentially impact study data, ethical study conduct, global regulatory, and AbbVie compliance, and you will provide quality control and compliance support for internal audits and regulatory authority inspections of Clinical Pharmacology and ACPRU.
Responsibilities
- Ensure compliance with corporate and divisional policies and procedures.
- Perform quality control reviews of regulatory, scientific, and clinical documents for Clinical Pharmacology.
- Receive and complete tasks and assignments from scientific teams and complete them within a time limit with minimal supervision.
- Lead project activities to ensure Clinical Pharmacology compliance with regulatory and corporate standards.
- Identify issues that potentially impact study data, ethical study conduct, global regulatory, and AbbVie compliance.
- Provide quality control and compliance support for internal audits and regulatory authority inspections of Clinical Pharmacology and ACPRU.
Requirements
- Bachelor's degree in a science-related field with +4 years of pharmaceutical/clinical research-related experience.
- Associate degree/RN with 9+ years of experience in the pharmaceutical industry may be considered.
- Good oral and written communication skills.
- Knowledge of clinical study principles with experience supporting clinical research, drug development, and/or therapeutic area operations.
- Ability to produce work of the highest quality by paying attention to detail.
- Ability to appropriately and effectively use resources to complete tasks and meet required timelines.
- Experience reviewing scientific data.
- Competent in the application of standard business procedures (SOPs, ICH, Global Regulations, Ethics, and Compliance).
- Preferred experience with Cosmos, Vault, One-Vault.
Additional Information
- 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.
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