ABBOTT LABORATORIES Label Editor – LATAM (Latin America) Global Labeling Operations - Abbott Park, IL or Columbus, OH Salary in the United States

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 103,000 colleagues serve people in more than 160 countries.

Location:  Abbott Park, IL or Easton, Columbus, OH

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 ensures 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.

MAIN RESPONSIBILITIES

Prepare and collect label development information required to initiate label development 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 packet

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

Collaborate with the Project Management group to meet committed product launches by ensuring label issues are resolved in a timely manner

Review label development documentation for accuracy and compliance to current policy, process and procedure

Skills/Experience/Requirements:

Basic Qualifications: 

• Understanding of processes (label initiation, development, and approval coordination).
• Effective communication with internal customers (affiliates, regulatory affairs, materials management, project teams, etc.) and external customers (print suppliers, translation agency, etc.).
• Ability to work well as a team player.
• Ability to adapt quickly and effectively to shifting priorities.

Preferred Qualifications:

• Education Requirements: BA or equivalent plus 4 years relevant experience