Specialist, Global Labeling Operations

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 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.
• Scope of label changes includes Regulatory Affairs for labeling submissions, AbbVie manufacturing sites, third party manufacturers and third party contracts.
• Complete work according to established priorities, policies, practices and procedures to assure deliverables meet requirements.
• Collaborate and communicate with key stakeholders in the label change process for production and submission artwork to prioritize deliverables.
• Comply with the labeling change schedule to meet established timelines. Communicate and negotiate exceptions to planned delivery dates.
• Interact with key stakeholders such as Regulatory Affiliates and Packaging Engineering, as needed, to successfully execute label change requests and Proofreading for the verification of developed label copy against the source documents.
• Ensure tasks are completed according to Right First Time principles
• 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.

• Bachelor’s Degree in Business / Engineering/Sciences preferred. Equivalent successful industry experience (minimum 2 years) can be considered (see below for guidance).


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


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


• Aware 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. ​

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.