Clinical QC Compliance Associate III (Hybrid, IL Based)

Company Description

AbbVies 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 peoples 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.

Job Description

Responsible for compliance with applicable Corporate and Divisional policies and procedures.

Perform Quality Control review of regulatory, scientific, and clinical documents for Clinical Pharmacology.

Responsible for receiving and completing tasks and assignments from the scientific teams and completing them within a time limit with minimal supervision.

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.

Identify issues that potentially impact study data, ethical study conduct, global regulatory and AbbVie compliance and identify potential interventions or solutions to manage the issues.

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

Bachelor’s degree in science related field with 4 years Pharmaceutical/Clinical research related experience.

Associate degree/RN with 9 years of experience in pharmaceutical industry may be considered.

Must possess 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 application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance).

Preferred experience with 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: ​

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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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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 Company’s 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, 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.

US & Puerto Rico only – to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html