Description
The Labeling Associate supports the compliant and timely publication of product information, ensuring SPCs and PILs are accurately prepared and supported with complete, inspection-ready documentation.
Working closely with Labeling Managers and other stakeholders, the role maintains labeling systems, workflow tools, and mailboxes, and supports regional labeling and artwork activities according to business needs.
Job Responsibilities
- Manage labeling publication: process approved SPCs and PILs for countries including UK and Ireland, monitor incoming requests, confirm that required documents and supporting information are complete.
- Prepare and publish approved documents accurately: complete administrative formatting, upload documents to the correct portal, and complete associated actions.
- Complete publication checks and follow-up: monitor portal notifications, quality-control comments, approvals, and publication status, and verify that the correct document and version are available.
- Maintain compliance records and tracking: keep a complete, accurate, and inspection-ready audit trail; work in accordance with approved procedures, Job Aids, and portal guidance; meet established timelines.
- Identify and resolve issues: identify incomplete or inconsistent requests, obtain missing information, support independent quality checks, and resolve portal issues.
- Provide operational and administrative support to Labeling Managers where appropriate.
- Support Labeling Managers by maintaining system management for labeling activities.
- Monitor system data integrity and quality checks.
Requirements
- Degree in life sciences, pharmacy, or a related field, or equivalent professional experience.
- Hands-on experience related to development, maintenance, and commercialization activities.
- Demonstrated ability to build strong, positive working relationships across multiple cultures and locations.
- Strong administrative, document-management, or operational skills, with demonstrated accuracy when handling detailed information.
- Good written and verbal English, and competence using Microsoft Office applications.
- Ability to work independently, while recognizing when guidance or escalation is required.
- Ability to work under tight timelines and apply sound judgment.
Nice to Have
- Experience in a pharmaceutical, healthcare, regulatory, or other highly regulated environment.
- Experience in labeling, artwork, regulatory affairs, publishing, document management, quality/compliance, controlled records, or audit trails.
- Familiarity with SPCs, PILs, product information, or international team working.
- Preferred experience with business analytics tools.
- Proven technical aptitude and the ability to quickly learn new software, regulations, and standards.
- Ability to speak an additional European language.
Work Location Assignment: Hybrid (some office presence is required)