Manager, Graphics Design - Remote

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.

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.

The role also manages the development of, and company adherence to, cGMP compliant prescription pharmaceutical labeling artwork control and approval systems and procedures. It 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. The position is responsible for security and control of Eisai Raleigh managed product labeling artwork files and electronic labeling artwork file systems, and 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, determining 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 are necessary to define, facilitate, 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.

The Manager also manages contract service providers (proofreaders, backup graphic designers, and any additional graphics service providers) and stays abreast of current pharmaceutical labeling artwork trends, requirements, best practices, and new technology relevant to product labeling, collaborating with other functional groups and maintaining membership in industry‑related packaging organizations such as IOPP/PmDLC.

• Creation, development and control of pharmaceutical labeling artwork for contractor‑packaged prescription drug products, collaborating directly with Supply Operations, Contract Manufacturing Operations, 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.
• Facilitate communication between cross‑functional teams to support end‑to‑end labeling and timely implementation of regulatory updates.
• Provide 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, facilitating global product launch initiatives.
• Collaborate with Technical Operations during development of new packaging components for launch or line changes and develop test component artwork to support package line initiatives.
• Strengthen and maintain cGMP compliant procedures for prescription pharmaceutical labeling artwork control and approval, collaborating with…