Artwork Coordinator (packaging) " >Artwork Coordinator (packaging)

Nov 17, 2021

Job Description

-Provides the labeling/artwork strategy, regulatory intelligence and knowledge which are required to develop, market, and maintain products. Provides strategic labeling input and support for global development projects and/or marketed products. Reviews labeling change information, and ensures that it is supported by the data and consistent with the application. Supports and assists the development and participates in negotiations on later stage products with regulatory agencies on approval of label

Major accountabilities
-Maintains regulatory compliant, competitive, and up-to-date core labeling documents for assigned products. The assigned responsibilities should in general be established products of lower complexity. -Research and understand the labeling topic including reviewing labels across different markets, competitor labels, study information, labeling regulations, etc. -Contribute to RA activities regarding Novartis safety risk communications/portfolio stewardship activities having labeling impact for their assigned projects/products. -Developing professional expertise, applies company policies and procedures to resolve a variety of issues. -Frequent internal company and external contacts. -Represents organization on specific projects -Refers to established policies and procedures for guidance. -Contributes to some cost center goals and objectives Responsible for all planning and operational aspects of artwork management within the Pharmaceutical Affairs and Product Lifecycle Management (PA&PLM) department. Single point of contact and subject matter expert for artwork process.As a member of the PA&PLM leadership team, you are in charge of all planning, and operational management and activities linked to Artwork Operations to ensure all Sandoz BeLux artworks are in compliance with cGMP regulatory requirements and the Novartis Pharma Quality Manual & Policies. -Planning and follow-up of all artwork related operational activities, projects and electronic tools. This includes all secondary packaging materials (leaflet / labels / printed foils / boxes / ...) for the Sandoz BeLux portfolio. -Responsible for artwork change control follow-up. -Be the single point of contact and link between all stakeholders within Sandoz BeLux and the different the manufacturing sites linked to the artwork process. -Guarantee efficient and transparent execution of the tasks in support of legal requirements and business needs. -Author, review and approve GxP documents and reports like SOP’s, KPI trends & performance reports, and technical or quality investigations. -Management of version control and archiving of artwork versions -Provide technical guidance, mentoring and support to other departments (where relevant) on artwork processes. -artwork project management, -process optimization -3rd party management (external graphics designers)

Minimum Requirements

Managing Change Interpersonal Savvy Being resilient
Collaborating across boundaries Functional Breadth Cross Cultural Experience
English French Dutch
Project Management Accountability
3-4 years relevant experience
Research & Development
Full Time
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Artwork Coordinator (packaging)

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