Company Description

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.

Job Description

Responsibilities

• Responsible for implementing and maintaining the effectiveness of the quality system by delivering the “perfect label” to our customers through an effective and efficient label change management process. The Perfect Label is defined as compliant with content requirements and timely implementation, both internal and external to AbbVie.

• Collaborate with key stakeholders to create and execute label change strategy for key label change projects, and labeling changes for early development, submission and production artwork to prioritize deliverables.

• Comply with the labeling change schedule to meet established timelines. Communicate and negotiate exceptions to planned delivery dates.

• Lead role to represent Label Center in early development labeling work including functioning as lead Label Change Coordinator for labeling launch activity.

• Identify continuous improvement ideas to improve right first time and schedule conformance.

• Apply packaging rules and regulations to creation and development of AbbVie’s artwork.

• Evaluate the impact of a label change on associated labels and manufacturing operations.

• Ensure completeness, accuracy, and control of changes in labeling including maintenance of labeling related specifications and documentation associated with these specifications.

• Work closely with Graphics in the creation of label artwork, mock ups utilized for regulatory submissions, and assist commercial, as required, in the development of label designs for packaging and labeling commodities.

• Work closely with Proofreading for the verification of developed label copy against the source documents.

Qualifications

Qualifications

• Bachelor’s Degree in Business / Engineering/Sciences preferred. Equivalent successful industry experience (minimum 4 years) can be considered (see below for guidance).

• Minimum of 4 - 6 years combined experience from totals: Quality/Regulatory– 2 years, Operations – 2 years, Pharmaceutical/Device Regulations – 2 years.

• Individual must have a breadth of experience to establish and maintain credibility across functions, with stakeholders and with senior management.

• Ability to motivate and influence others over whom they have no direct authority.

• Knowledge of applicable regulations and standards affecting Pharmaceutical, Device, Device/Combo Products, specifically regulations and standards affecting the Packaging and Labeling Quality System.

• Ability to logically reason, solve problems, and make decisions on key issues independently.

• Self-motivated and strong focus on details and accuracy.

• Strong written and interpersonal communication skills.

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.

Additional Information

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.