Label Coordinator (temporary 6 months)

Job description

The label coordinator ensures the delivery of high quality labels to the Clinical Supply Chain within the agreed upon timelines.

· Creates Investigational Medicinal Product labelling in Janssen label generation systems. Ensures that labelling complies with source documentation, local regulatory requirements, internal procedures and technical specifications.
· Defines Master English Label texts in alignment with the Annex 13 guidelines and internal procedures.
· Reviews translation data base (Lexicon), Master English Labels, labels and booklets against documentation to ensure accuracy and compliance.
· Responsible to manage all labels (production + submission labels) for a specific compound in close collaboration with responsible Batch Doc and Label Coordinators (BD&LC). Confers with Local Medication Coordinators (LMCs) both internal and external (GCO & Quintiles), Clinical Supply Integrator, Trial Supply Managers throughout label creation to keep them informed of status of job, to solicit and resolve inquiries and complaints, to obtain approval of artwork and to procure information needed to process the order.
· Acting as an expert in the Technical Team on label requirements. Influence the team in taking decisions in compliance with label regulations.
Escalates to Team lead in case of requests for deviations or non-agreement.
· Develops a workload planning driven by constant changes in priority. Closely follow-up on supply plan milestones to guarantee timely availability of labels. Closely follows up on submission timelines in consultation with Clinical Supply Integrator and/or Team lead.
· Maintains a detailed knowledge of clinical label requirements, end-to-end label processes and current Good Manufacturing Practices (cGMP).
· Responsible for vendor management (external booklet/label creation and printing process).
· Provide input to improve the label end to end process in order to optimize quality, compliance and the timely delivery.

Desired profile

·  Minimum of bachelor or equivalent through experience.
·  Knowledge of GMP and Good Documentation Practices
·  Knowledge of Office applications (MS Word, MS Excel, MS PowerPoint) and Acrobat.
·  Knowledge of Graphic systems in an asset
·  Fluent in English