Welcome to AbbVie!
We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. Redefining what is possible is our business and our passion. Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work.
We are recruiting a Global Labeling Operations Specialist to join our diverse team in AbbVie North Dublin in Clonshaugh. Global Responsibility for operations labeling project execution within a highly cross functional environment and key subject matter expert on regulatory, manufacturing, and commercial labeling considerations to ensure the Global Label Management organization meets its performance objectives. 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. Function as key subject matter expert within Operational Labeling and liaise primarily with Regulatory Affairs, Packaging Engineering and Manufacturing. Ensure tasks are completed according to Right First-Time principles. Collaborate closely with Proofreading and Artwork Development in support of development of label designs and verification of developed label copy against the source documents.
Are you intrigued? Do you want to learn more?
· 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
So, what do you need to do this role?
·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.
·Proficient in English language
·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
It’s important to remember, AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.
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.