Sr US Artwork Manager - Ampcus Incorporated
chicago, IL
About the Job
"The Sr. US Labeling Artwork Manager is a subject matter expert for ensuring high quality US printed packaging components and related artwork activities for Innovative Medicine products. This role is responsible for the development of manuscripts for printed packaging components and supports artwork development for assigned products in compliance with processes and regulatory requirements. In addition, drives process improvement initiatives and provides strategic guidance and training to US Labeling Artwork Specialists and Managers. The main activities are preparation, review, and approval of US related artwork, in coordination with Country Organization (CO), US CO QA and other stakeholders. This position also directly establishes operating policies and procedures related to the functional area, drives process improvement initiatives, and leads required operational activities related to Global Labelin"
Responsibilities
• Lead end-to-end project management of new US artwork creation for new product launches
• Liaise with GPRM/GPRD and relevant stakeholders to obtain required content and information for development of US artwork.
• Lead, initiate and coordinate mock-up and text change requests, including safety label changes, for US artwork in the ‘Artwork Change Request Tool’ based on the labelling/artwork standards, regulatory and requestor requirements.
• Review and approve US related artwork in artwork tool using both manual and electronic methods. Approve the Printed Packaging Material Sheet (PPMS).
• Ensure final artwork accurately represents the approved text.
• Ensure consistency of across artwork (e.g., regulatory content, branding, as Effective version: 01-MAY-2019 Business Use Only applicable) within a product family
• Lead complex artwork/labelling projects affecting multiple products where collaboration and coordination across functions is required.
• Ensure timely communication on projects and issues to key stakeholders and higher management.
• Subject Matter Expert (SME) for complex issues and query resolution related to US Artwork Presentations.
• Lead training, mentorship, and strategic guidance to new associates. SME in process development /improvement related to Artwork (e.g. SOPs, Working Practices, Working Instructions, etc.)
• Develops advanced concepts/approaches; develops new applications and is an expert within organization.
• Solves complex problems, which require ingenuity, innovation, and creativity. Solutions may set precedence for future decisions. Guide new product teams in planning and launching new products and/or new indications to ensure compliance with US artwork requirements.
• Liaise with RA GPRD and GPRMs; CMC/TRD; Marketing; Package Engineers; Production Planning; Strategic Sourcing; third party co-marketing partners; and customer representatives concerning projects, scheduling, contracts, or operations, as required.
Experience
• Effective planning, organizational, and interpersonal skills. Computer skills (i.e., MS Office, etc.). Strong written and verbal skills.
• Ability to work with and/or lead project teams, multi-task. Knowledge/experience of US regulations, guidelines
Responsibilities
• Lead end-to-end project management of new US artwork creation for new product launches
• Liaise with GPRM/GPRD and relevant stakeholders to obtain required content and information for development of US artwork.
• Lead, initiate and coordinate mock-up and text change requests, including safety label changes, for US artwork in the ‘Artwork Change Request Tool’ based on the labelling/artwork standards, regulatory and requestor requirements.
• Review and approve US related artwork in artwork tool using both manual and electronic methods. Approve the Printed Packaging Material Sheet (PPMS).
• Ensure final artwork accurately represents the approved text.
• Ensure consistency of across artwork (e.g., regulatory content, branding, as Effective version: 01-MAY-2019 Business Use Only applicable) within a product family
• Lead complex artwork/labelling projects affecting multiple products where collaboration and coordination across functions is required.
• Ensure timely communication on projects and issues to key stakeholders and higher management.
• Subject Matter Expert (SME) for complex issues and query resolution related to US Artwork Presentations.
• Lead training, mentorship, and strategic guidance to new associates. SME in process development /improvement related to Artwork (e.g. SOPs, Working Practices, Working Instructions, etc.)
• Develops advanced concepts/approaches; develops new applications and is an expert within organization.
• Solves complex problems, which require ingenuity, innovation, and creativity. Solutions may set precedence for future decisions. Guide new product teams in planning and launching new products and/or new indications to ensure compliance with US artwork requirements.
• Liaise with RA GPRD and GPRMs; CMC/TRD; Marketing; Package Engineers; Production Planning; Strategic Sourcing; third party co-marketing partners; and customer representatives concerning projects, scheduling, contracts, or operations, as required.
Experience
• Effective planning, organizational, and interpersonal skills. Computer skills (i.e., MS Office, etc.). Strong written and verbal skills.
• Ability to work with and/or lead project teams, multi-task. Knowledge/experience of US regulations, guidelines
Source : Ampcus Incorporated
