The Clinical Label Creator / Coordinator will be responsible for designing label artwork for a global portfolio of Investigational Medicinal Products (IMP). Additionally, they will collaborate with Local Label Representatives (LLRs) in various countries to ensure label content meets the applicable regulations in the associated country. These labels can be used for internal manufacturing or used at a Contract Manufacturing Organization (CMO) and the Clinical Label Creator / Coordinator is responsible for ordering and managing the inventory of required labels for scheduled manufacturing operations. In general, the Clinical Label Creator / Coordinator will be responsible for managing all aspects of clinical label creation, inventory, and will interface with the Clinical Planning organization, manufacturing execution teams, material suppliers, and the Quality organization as part of their daily tasks.
Create and revise labeling artwork for Investigational Medicinal Products (IMP) and ensure label contents meet all medical, legal and regulatory requirements.
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.
Proofread labeling artwork and incoming vendor proofs.
Represent the label team in cross-functional and production meetings.
Collaborate with various internal functional group members and external suppliers to provide labeling solutions in support of domestic and global clinical trials.
Actively participates in global and local projects and kaizens to optimize Clinical Supply. In some cases, leads projects specifically to improve the label process.
Communicate timelines and provide project updates to customers, global manufacturing sites, and business partners.
Drives and leads issue resolution with the label print room, vendors, and other key stakeholders.
Responsible to escalate any major label related issues to the Head of Clinical Supply Operations.
Monitor changes in labeling regulations from domestic and global agencies, including fulfilling the role of Local Label Representative (LLR) for some countries as well as liaising with Local Label Representatives (LLRs) in Roche’s affiliate organizations on global translations.
Evaluate, recommend, and implement improvements to the labeling process, quality, systems and policies using the Lean Production System (LPS) principles.
Develop expert level skills in the applicable software used for label creation (i.e. SAP Global Label Management (GLM), Prisym ID, etc.)
Create, update, and maintain label related documents, for example SOPs, Phrase Library, etc.
Accountable for ordering labels from vendors and monitor order status and availability and inventory. Must ensure that labels are available to meet production schedules and project timelines.
Complete label delivery inspections. Is accountable for ensuring correct labels are delivered and participates in the label release process.
Actively monitors Key Performance Indicators (KPIs) for team performance, vendors, and in-house label printing activities and works independently to develop ideas and initiate
Supports label system change requests and act as Label Creation System Superuser
B.A. or B.S. degree with 2+ years work experience in the pharmaceutical, biopharmaceutical or related industry, or a Master’s Degree with 1+ years relevant experience, or an equivalent combination of education and experience.
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.
Possess strong analytical skills, high attention to detail, and understanding of systems and technical designs
Full use and application of basic Supply Chain/Business Process/cGMP theories, principles, and techniques
Ability to effectively interpret Quality standards for implementation
Ability to manage projects from initiation to delivery
Ability to work independently. Self-motivated, proactive, quick thinking, and adaptable. Ability to set priorities and to remain flexible in stressful situations
Ability to communicate clearly and professionally both in writing and verbally
Ability to quickly learn a broad range of skills
Flexibility in problem solving and work hours to meet business objectives
Excellent English skills
Prefered skills and/or experience
Demonstrated project management skills
APICS CPIM certification
Experience with SAP ERP systems
Experience with Prisym ID label creation software
Experience in Pharma Regulatory teams
NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks.
AGENCY NOTICE: Please note that Roche Canada does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Services Agreement with agency/recruiter, Roche Canada will not consider or agree to payment of any referral compensation or recruiter fee. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement, Roche Canada explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.
Job Level:Individual contributor