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A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.

That’s what makes us Roche.

Within Production Enablement the Global Clinical Artwork Manager is responsible for designing label artwork for a global portfolio of Investigational Medicinal Products (IMP). You collaborate with Local Label Representatives (LLRs) in various countries to ensure label content meets the applicable regulations in the associated country. The Global Clinical Artwork Manager is responsible for ordering the required labels for scheduled manufacturing operations. In general, you will be responsible for managing all aspects of clinical label creation and controls the life cycle of all kind of clinical artwork labels. You will  interface with the global Clinical Planning organization, manufacturing execution teams, external vendors, the global network of Local Label Representatives (LLRs) and the Quality organization as part of your daily tasks.

The Opportunity:

You will create and revise labeling artwork for Investigational Medicinal Products (IMP) and ensure label contents meet all medical, legal and regulatory requirements. 

You will be accountable for the clinical label life cycle for various label types, for example, booklet labels, single panel labels, shelf-life extension labels, and new or unique labels. 

You will  monitor changes in labeling regulations from domestic and global agencies and manage implementation of requirement changes to clinical artwork labels

You will represent the label team in cross-functional and production meetings and projects as well as collaborate with various internal functional group members and external suppliers to provide labeling solutions in support of domestic and global clinical trials.

You will communicate timelines and provide project updates to customers, global manufacturing sites, and internal and external business partners. In addition you will lead issue resolution in the label creation process with the label print room, external vendors, and other key stakeholders. 

You will also drive the label approval process, granting timely content approval by all Label Representatives and fulfill the role of Local Label Representative (LLR) for some countries 

You will evaluate, recommend, and implement improvements to the labeling process, quality, systems and policies using the Lean Production System (LPS) principles. 

Who you are 

You will have 3+ years experience in the pharmaceutical, biopharmaceutical industry and/or Supply Chain Management with Associate level of professional education /University degree/Masters  in the pharmaceutical, biopharmaceutical or Supply Chain Management, or a Master’s Degree 

Your technical skills will include experience with SAP ERP systems with an APICS and/or SCOR certification, or equivalent relevant experience 

You will have a Solid understanding of the Pharma Supply Chain 

Your high cultural awareness and social competence required as cooperation and communication in complex situations with different cultures and countries is part of the daily job including well-developed teamwork, collaboration, and negotiation skills 

You will be an expert in use and application of basic Supply Chain/Business Process/cGMP theories, principles, and techniques 

Preferred:

Experience in Pharma Regulatory preferred 

PMP/Operational Excellence/Six Sigma/Lean training a plus

** Relocation benefits are not available for this position**

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche's truly innovative culture.

Roche is an Equal Opportunity Employer.