AbbVie

Global Labeling Operations Manager

Employer
AbbVie
Location
Irvine, California
Posted
May 25, 2021
Ref
2108245
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Purpose:

Leader for labeling project management, strategic and tactical label change planning and forecasting to ensure the Global Label Management organization meets its performance objectives. The position will lead packaging and artwork strategy and shared label strategy across the prescription and OTC product lifecycle. Responsibility to lead cross functional teams and drive alignment for labeling projects including manufacturing, engineering, regulatory and supply chain to achieve the Perfect Label. Ensures assurance of supply; compliance to content; and implementation of approved labeling for new product launches, safety updates and other core labeling programs

 

Responsibilities:

  • Global product leadership for strategic and tactical planning for label change projects
  • Responsibility for accuracy and completeness of the change request phase within the Artwork Management System.
  • Project Management responsibility within the Artwork Management System and utilizing other internal systems necessary for labeling changes.
  • Lead label change projects and associated deliverables for early labeling development, launches, site transfers, country/area specific changes and other labeling focused projects while working closely with Regulatory, Marketing, Supply Chain and manufacturing/packaging site.
  • Lead the periodic formal review process for label change management and develop and report performance metrics within label change execution.
  • Ownership and leadership role within the Packaging and Artwork Strategy
  • Lead shared label strategy development and maintenance over the product life cycle
  • Change Plan ownership for labeling operations. Initiate labeling artwork change requests and collate all changes into the change request.  
  • Act as Subject Matter Expert for specific labeling business processes, work within an artwork management system and provides suggestions for process and system improvements
  • Assign NDC numbers for products/bulks along with the creation and maintenance of GTINs.
  • Continuously monitor company website and Dailymed to ensure current USPIs are posted correctly.
  • Create, update, maintain labeling for Abbreviated New Drug Applications (ANDA), Biologics License Application (BLA), New Drug Application (NDA) and Authorized Generics products.
  • Prepare labeling documents for FDA submissions and annual reports summary of labeling changes.
  • •nterpret packaging/labeling changes from FDA feedback on NDA submissions
  • Collaborate with cross-functional team members to ensure quality and inventory is met with required labeling.

Qualifications

Qualifications:

  • Bachelor's Degree in Science, Engineering, Business or Supply Chain and minimum of 5 years' experience in Operations, Regulatory or Quality environment
  • Proficiency in English (both written and oral)
  • Experience working effectively across different cultures, multiple functional areas and in complex matrix environments
  • Excellent written and oral communication skills with all levels of management and personnel.
  • Demonstrated success in negotiating and problem solving skills
  • Strong interpersonal and organizational skills
  • Excellent leadership skills and a proven ability to drive cross functional collaboration.
  • Understands Regulatory, Quality and Supply Chain aspects of labeling and impact of non-compliance
  • Proficiency in regulations and standards affecting Pharmaceutical, Device, Device/Combo, and OTC Products, specifically regulations and standards related to  the Packaging and Labeling.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.