his position participates in tactical & strategic planning to develop a state-of-the-art labeling design organization. Lead initiatives related to development and implementation of design systems in preparation for upcoming product launches and ongoing commercial operations. Work with functional groups including Regulatory Affairs, Quality Assurance, Commercial, Legal, Packaging Engineering, and Manufacturing to further refine the process for design & development of clinical and commercial labeling. Work with Commercial and Regulatory to develop and finalize graphic elements and product branding elements of labeling for EU, US and ROW. Develop estimates for labeling component printing quantity and cost requirements to support needed clinical and commercial activities. Review and approve packaging artwork for accuracy, regulatory requirements and production requirements. Lead drafting, review, update (as needed) and approval of function SOPs. Identify, develop and lead opportunities for continuous improvement for deliverables and processes. Lead sub-groups and teams as required to assist in product launches. Evaluate capabilities and capacities of current or proposed suppliers. Work with bluebird bio’s Supplier Relationship Management & Quality teams to qualify and on-board labeling/packaging suppliers. Participate in technical supplier audits. Be single point of contact for suppliers and coordinate with cross functional team to review and resolve supplier service performance expectations to ensure bluebird bio requirements are being met. Work with Finance team to create/maintain label design budget, PO creation and invoice payments. Lead design activities for creating labeling/packaging artwork, preparing associated specifications, managing related electronic labeling systems and quality systems and coordinating printing for both clinical and commercial labeling.
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