Label Specialist

Job description

Job Description

Requisition ID: 1805699719W

The Label Specialist develops and drives the optimization, harmonization and further alignment of all label processes and systems. The label specialist understands the full end to end process and has an overview of how the processes of key project implementations impact different functional area and ultimately patients enrolled in clinical studies. The Label Specialist develops and drives the optimization, harmonization and further alignment of all label processes and systems.

DESCRIPTION OF THE ROLE

·  Maintains a detailed knowledge of clinical label requirements, end-to-end label processes and GMP.
·  Represents the Label Group in core project team initiatives.
·  Acting as an expert in technical teams on label requirements. Influences the team in taking decisions in compliance with label regulations. Escalates to Team Lead in case of requests for deviations or non-agreement.
·  Is the Janssen packaging and labelling systems expert (NGENCODAC) from a Label Group perspective.
·  Tests and implements, when appropriate, new technologies related to Labels.
·  Manages all label system control/validation activities (follow up, testing and documenting).
·  Trains the international user community (Local Medication Coordinator [LMC], Clinical Supply Integrator, Trial Supply Manager) in NGENCODAC and label workflows.
·  Participates actively in global initiatives to optimize processes in line with the Process Excellence Methodology.
·  Constantly strives for optimization and harmonization of methodology, guidelines, processes and documentation globally (procedures, guidelines, work instructions, etc) related to the end to end label process.
·  Responsible for vendor management (external booklet/label creation and printing process)
·  Confers with LMCs on new or updated country specific requirements, agrees together with label process owner on implementation.
·  Creates Investigational Medicinal Product labelling in NGENCODAC and ensures that labelling complies with source documentation, local requirements and technical specifications.
·  Defines Master English Label Texts in alignment with current regulatory guidance documents, e.g., Annex 13 guidelines and internal procedures.
·  Responsible to manage all labels (production + submission labels) for a specific compound in close collaboration with responsible Batch Doc and Outsource Coordinators (BD&OC). Confers with LMCs (internal and external), 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.
·  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.
·  Acts as an application administrator for NGENCODAC.
·  Coordinates and organizes internationally the NGENCODAC Help Desk for all internal and external customers related to the label workflow.

Desired profile

Qualifications

Requirements
·  Minimum of bachelor or equivalent through experience (generally requires 3-5 years labelling related experience)
·  Knowledge of GMP and Good Documentation Practices
·  Experience within a clinical packaging unit is an asset
·  Knowledge of Graphic and Printing processes is an asset
·  Experience in process and system optimization/validation is an asset
·  Process Excellence knowledge
·  Knowledge of Office applications (MS Word, MS Excel, MS PowerPoint) and Acrobat
·  Fluent in English

Primary Location
Belgium-Antwerp-Beerse-
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
Administration
Requisition ID
1805699719W