. Provide project management and coordination of labeling changes by interfacing with Marketing, R&D, Regulatory, Technical Communications, Legal, Package Engineering, and Site Operations.
. Create or support development of various required labeling components, including labeling requirement plans, technical information charts, graphics and/or schematics, label formats and final product labels.
. Develop and provide redlines and coordination for the preparation of labeling as well as any supportive illustrative materials and labels, based upon departmental procedures and supervisor's direction, as well as input from cross functional subject matter experts.
. Provide input to task-related schedules and update timelines of new and revised labeling
. Ensure assigned deadlines are met and raise any challenges or issues to supervisor.
. Understand and apply applicable labeling regulations and standards as interpreted by departmental or site procedures.
. Review and release labeling for product labels, cartons and other related materials and ensure appropriate review by SME regarding medical, legal, and regulatory requirements for medical devices.
. Works with labeling system database(s) related to development of required label information.
. Ensure accuracy and consistency of labeling, timeliness of changes and overall approval of label.
. Coordinate the review and approval for all new and revised labeling and the translation of labeling through internal or external sources as required.
. Experience working on multi-disciplinary teams and projects.
. Highly detail oriented
. Experience working in label design software, such as Adobe InDesign, Adobe illustrator, and Microsoft Office programs.
. Bachelor of Science or Bachelor of Art in related fields is REQUIRED.
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