Manager, Graphics Design - Remote

Eisai is a growing pharmaceutical company focused on neurology and oncology, dedicated to improving healthcare for patients and their families. The Manager, Graphics Design is responsible for the design and development of pharmaceutical product labeling artwork, ensuring compliance with regulatory requirements while collaborating with various internal and external stakeholders.

Responsibilities:

• Creation, development and control of pharmaceutical labeling artwork for contractor-packaged prescription drug products
• Collaborates directly with Supply Operations, Contract Manufacturing Operations (CMOs), multiple external contract packaging sites, country specific Global Regulatory Affiliates, Marketing, Technical Operations, Quality Assurance, and Corporate Alliance Partners to provide high quality, regulatory compliant labeling artwork for commercial products managed by Eisai Raleigh site
• Facilitates communication between cross-functional teams to support end-to-end labeling and timely implementation of regulatory updates
• Provides pharmaceutical product labeling artwork to meet critical path deadlines for new US and ROW product launches and / or submissions to the FDA and other country specific regulatory authorities, to facilitate global product launch initiatives
• Collaborates with Technical Operations during development of new packaging components for launch or line changes and develops test component artwork to support package line initiatives
• Strengthens and maintains cGMP compliant procedures for prescription pharmaceutical labeling artwork control and approval
• Collaborates with management of affected departments to ensure cohesive working relationships and to meet shared objectives
• Management of contract service providers for support of labeling artwork procedures & systems to maintain and control current and retired FDA approved labeling artwork files
• Management of contract design services as needed to support high volume critical path projects

Requirements:

• Bachelor's degree in graphic design
• 1-year related work experience in the pharmaceutical industry
• High skill level and understanding of design programs on Macintosh platform. Direct experience with Adobe Creative Cloud required
• Knowledge and experience with labeling security and serialization features
• Understanding of and direct experience with cGMP and FDA Regulatory prescription pharmaceutical labeling requirements
• Understanding of and direct experience with ROW, Canada, and emerging market country-specific labeling artwork requirements
• Ability to work independently and effectively, prioritizing assignments without supervision
• Highly developed interpersonal skills are required to effectively deal with all levels of personnel from executives to non-exempt and outside vendors
• Ability to exercise independent judgment and initiative on labeling matters
• Demonstrated initiative, results oriented, willingness and ability to institute change
• Process oriented with a strong interest in continuous improvement