Job Description

Liaise with project teams, commercial colleagues, manufacturing, and in-country regulatory affairs managers to ensure alignment on content and subsequently thorough review of drafts to provide accurate editor’s copies to the company artwork center.

Facilitate translation with internal partners and review of translations by in country regulatory affairs managers.

Utilize checklist and Outline of Production to ensure label compliance with USDA and global regulatory expectations.

Generate new or revised editor’s copies of labels.

As applicable, utilize company systems for entry and tracking of regulatory activities.

Manage and communicate accurate timelines for deliverables including use of Asana for regular updates.

Train others on aspects of the global procedures necessary for stakeholders to fulfill their role in the artwork process, e.g., ensure others have sufficient knowledge of how to complete artwork request forms, prerequisites, and impact of sudden changes to the artwork on overall timeline.

As needed, coordinate multi-disciplinary meetings to ensure alignment on the artwork requests and to resolve complex issues.

Participate in and/or lead efforts continuous improvement efforts, e.g., review, revise, and/or create new artwork global work instructions for specialized situations, such as instrument related artwork, or online instructions.

Manage challenging situations including contributing to decisions related to escalation to leadership and/or requests for acceleration.