Sr. Labeling Specialist - LATAM Global Labeling Operations - Columbus, OH

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives.

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Columbus, OH location in the Nutrition Division.

Our ambition is providing innovative high-quality products, creating sustainable value, delivering superior user experience and enhancing health outcomes at all stages of life. Demonstrate stewardship in the application of QA policies and procedures, projects, and systems used to develop Abbott Nutrition product labels.  This individual serves as the primary reference for product labeling and as such evaluates proposed labeling changes and implements the changes, along with developing new primary and secondary product labels as prioritized by the project management group.  Focus of the role will be labels that are marketed within the assigned countries of the LATAM Commercial Region.  The individual will utilize project management skills to ensure that the label development process flow is adhered to.  The individual is the primary contact within the working team (Labeling Manager, Desktop Publisher, Affiliate, Area Regulatory Specialist, Project Management Group) for planning, start-up, and execution of the label development activities through the labeling quality system and ensures labels are reviewed, approved, and completed. The individual also serves as primary contact for the external translation agency.

What You’ll Work On

• Oversee all aspects of assigned projects, including planning, execution, monitoring, and evaluation.
• Prepare and collect label development information required to initiate label start-up activities.
• Complete label development activities required to promote label packets from review to approval phase.
• Responsible for selecting appropriate label packet workflow and assessing all applicable reviewers(s) and approver(s).
• Ensure all appropriate documents are within the label packet in the designated quality (Change Control) system.
• Responsible for the accuracy and completeness of the label and supporting documentation.
• Primary contact for labels that require third party translation and request for translation service from third party translation agency as applicable and retain translation files and document records
• Work with and notify Regulatory contacts at Affiliate level of label readiness for registration submission
• Work with Plant Label contacts to coordinate implementation of the final label for product manufacturing
• Collaborate with Plant Label contacts to ensure barcode type and commodity numbers meet country requirements
• Manage timelines, elevations and collaborate with the Project Management group to meet committed product launches.
• Must have capacity for attention to detail wit