Overview

This position is responsible for managing and implementing the processes associated with the creation of new, and revision of existing, labeling content documents throughout the complete product lifecycle. This position partners with the appropriate groups and subject matter experts to drive product labeling development activities. The position is responsible for the accuracy of labeling documents and compliance with regulatory requirements, internal labeling processes and policies and associated change control. The position will be involved with participating in and responding to internal and external labeling audits, as well as activities related to the development and maintenance of applicable labeling procedures, guidelines, and templates. This position is responsible for partnering with multiple departments to manage and develop product structure and work instruction documents for manufacturing, warehouse and 3rd party distribution to correctly implement labeling on product. Additionally, this position is responsible for the development and delivery of training to pertinent functional units regarding labeling processes and supporting systems-based tools.

Responsibilities

• Work with the graphics and translations suppliers to create artwork, drawings and associated documentation for labeling.
• Ensure that labeling artwork and proofs are accurate and meet all medical, legal and Global regulatory requirements.
• Ensure regulatory compliance, accuracy, timely completion and version control of all new and revised labeling.
• Develop/update product structure and work instruction documents to ensure labeling is correctly implemented into product.
• Perform continuous coordination, monitoring and expediting of labeling changes to meet established deadlines for regulatory submission and production, as well as product launches.
• Structures ancillary teams such that all appropriate functions are present as needed during the label development and approval process.
• Serves as primary communication hub for team information regarding labeling. Develops and provides guidance for labeling as needed, such as use of pre-printed or CGL labels, translations, specific country or region label requirements and label production.
• Works with the initiator and/or the project team (Operations, Marketing, Regulatory Affairs, Quality, R&D and Clinical Affairs) to identify potential labeling issues and to define and implement solutions.
• Work with procurement and labeling print vendors to ensure correct labeling components are produced.
• Manage barcode processes and systems as related to product labeling.
• Working knowledge of computer generated labeling systems/output.
• Key Performance Indicators: Artwork/Labeling must be 100% accurate and meet submission and production schedules.
• Manages special project assignments to support Labeling as needed. This can include, but is not limited to, training, process improvements and procedure development.

Qualifications

Education:

• Bachelor’s degree from an accredited higher learning institution or higher in scientific field or equivalent in number of years of experience.

Experience:

• 5 years combined experience in the pharmaceutical, biologics or medical device industries with a minimum of 3 years of product labeling experience.
• Must have a thorough understanding of Global product labeling regulations and regulatory processes (medical/safety/regulatory/corporate).
• Proven ability to lead and work effectively in cross-functional teams to develop consensus on disparate issues, and have a general understanding of labeling operations relevant to product packaging/manufacturing processes.
• Strong problem solving skills.
• Experience in cGMP/GDP/GCP environments, packaging, and FDA regulated industries strongly preferred.
• Proficiency in Microsoft Word, Excel, and Adobe Acrobat required.
• Demonstrated expertise in managing the labeling content business process, including change control; knowledge of labeling content across all company products.

Compensation: $77,000 to $121,000 annual salary depending on experience.