Global Labeling Operations Specialist - AbbVie

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 X, Facebook, Instagram, YouTube and LinkedIn. 

Join our Collaborative Global Labeling Team!

The Global Labeling Operations Specialist role based in North Chicagois your chance to be part of a dynamic and inclusive team. The position will lead workflow coordination within artwork production and has responsibility for key tasks within artwork projects specific to (technical) redlining, technical documentation, commodity code assignment as well as disposition responsibilities within the workflow. We offer a culturally inclusive environment that empowers you to reach your full potential!

Please note for internals, grade may vary from country to country.

Responsibilities:

• Lead coordination within artwork production in artwork management system to ensure on time completion
• Complete redlining, tech doc and disposition tasks in the artwork management system
• Drive exception management for artwork workflow execution. Act as primary contact for stakeholders
• during artwork development, proofreading and approval to resolve any issues, coordinate recycles and
• provide support where needed to unsure workflow schedule is maintained
• Complete Change Plan tasks
• Understand performance within their area of responsibility and identify and implement continuous
• improvement opportunities
• Manage the labeling development and implementation schedule to meet established timelines and negotiate
• exceptions to planned delivery dates
• Act as owner for specific labeling business processes and assume role of documentation subject matter
• expert
• Key liaison and subject matter expert for packaging and labeling at AbbVie plants and Third-Party
• Manufacturers
• Own coordination of regulatory submission required commodity samples
• For US market only; manage drug listing, printed supply notification, and commodity specifications

• Bachelor’s Degree in Business / Engineering/Sciences preferred. Equivalent successful industry experience (minimum 4 years) can be considered
• Preferred: Labeling experience in Pharmaceutical or Biotech industry. Minimum of 4 - 6 years combined experience from the following areas: Quality/Regulatory, Operations, Pharmaceutical/Device Regulations.
• Understands Regulatory, Quality and Supply Chain aspects of labeling and impact of non-compliance.
• Demonstrate ability to work in a highly cross functional and global environment
• 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.
• Self-motivated and strong focus on details and accuracy
• Strong written and interpersonal communication skills
• High affinity to IT systems

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