Description
The Labeling Operations Specialist provides operational and project-management support for pharmaceutical labeling documents, including Core Data Sheets, United States Package Inserts, Summary of Product Characteristics, and related patient labeling documents. Responsibilities include generating and consolidating document renditions, managing workflows and document status, performing data-quality and proofreading checks, coordinating stakeholders, tracking review and approval timelines, preparing comparison tables and SPLs, and ensuring compliance with regulatory and company submission standards. The role requires a bachelor’s degree in a science or life sciences, 2–4 years of experience in a regulated environment, strong communication and project-management skills, and the ability to work in an office or remote environment with 5–10% regional or global travel.
