Manager, Graphics Design - Remote

Eisai • Woodcliff Lake, NJ

1d • Remote

About The Position

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
Job Summary:

The Manager, Graphics Design is a self-directed contributor responsible for design and development of pharmaceutical product labeling artwork for primary and secondary packaging of pharmaceutical products, package inserts, and trade labeling. These activities support proposed, new, and existing commercial products. This position demonstrates high level performance and delivers high quality labeling artwork design for product packaging on schedule to meet patient, company, and regulatory needs.
This position is responsible for development of, and company adherence to, cGMP compliant prescription pharmaceutical labeling artwork control and approval systems and procedures. This position requires continuous collaboration with multiple internal Eisai departments, Global Regulatory Affiliates, and Corporate Alliance Partners to assess labeling artwork needs and provide quality, compliant product labeling artwork for global product distribution.
This position is responsible for security and control of Eisai Raleigh managed product labeling artwork files and electronic labeling artwork file systems. This position manages the graphic design contract service providers as needed to support high volume, critical path projects.
The Manager, Graphic Design is a self-directed SME for labeling artwork management and control systems. This position determines how best to manage multiple projects and tasks to meet challenging, shifting timelines to support Eisai products packaged and/ or launched at external sites.
Extensive industry experience and independent decision making is necessary to define, facilitate and/or customize cGMP compliant pharmaceutical labeling artwork procedures and systems to manage ethical drug product labeling requirements for US and ROW country specific product packaging within project specific labeling formats that involve multiple levels of complexity.
Responsible for management of contract service providers (proofreaders and back-up graphic designer ) any additional graphics service providers that may be needed to support trade labeling.
The Manager, Graphic Design stays abreast of and conversant in current pharmaceutical labeling artwork trends, requirements, best practices, and new technology relevant to product labeling. Collaborates with other functional groups within the company and maintains membership in industry-related packaging organizations such as IOPP/PmDLC to understand industry trends and best practices. May participate in industry group meetings, forums and cross-company benchmarking efforts.

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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager