Label Specialist - Columbus, OH

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 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

• 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 with the ability to recognize errors in spelling, punctuation, and grammar.
• Ensure labeling packet is in compliance with medical, regulatory, marketing and country specific requirements.
• Able to manage multiple tasks and prioritize accordingly to meet challenging deadlines.

Education and Experience, You'll Bring

Required Education Requirements: BA or equivalent plus 4 years relevant experience. Spanish speaking is a plus, but not a requirement.

Preferred

• 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.).
• Desire for collaboration and the ability to work with both as a team and independently.
• Highly organized, self-motivated, adaptable and detail-oriented.
• Ability to adapt quickly and effectively to shifting priorities.
• Must be comfortable with technology and have the ability to learn quickly.
• Proficient with Microsoft Applications (Excel, Word, Outlook).
• Proficient with Adobe Acrobat.