Labeling Program Manager (Must have Medical Device Labeling)

Duties And Responsibilities

• Develops, revises, and reviews product package labelling, carton labels, and component labels to ensure compliance to global regulations.
• Analyzes product specifications and oversees development of documentation which may include instrument/software manuals, reagent package inserts, and labels for sustaining products.
• Ensures accuracy, clarity, appropriateness, and consistency of documents; reviews and may evaluate documents of other writers when appropriate.
• Serves as a resource to writers and label designers in areas of content development and label design.
• Fulfills a role in following logical, structured, and consistent thought processes when planning, speaking, and presenting in meetings.
• Possesses the ability to organize information into a clear and logical sequence.
• Performs gap analysis and makes suggestions for improvements to processes and procedures.
• Manages workload, timeline, and resources for a project; informs team early about possible issues; plans and prepares for possible issues and formulates a mitigation plan.
• Serves as a subject matter expert for product labels/inserts and/or instrument and software user's manuals.
• Works with R&D, Marketing, Quality, Medical, Regulatory, Supply Chain and plant teams and associates to develop/revise product labelling, user documentation and determine specifications for: type style, font size, clarity and conformity of wording, formatting and print/digital delivery.
• Assists with the development and implementation of packaging and labelling processes for BDB plants.
• Works with Label Control, Incoming Inspection, Operations and Quality to resolve quality issues regarding labelling, and developing internal and external procedures geared toward minimizing and eliminating labelling recalls.
• Develops, reviews, and maintains vendor specifications, graphic and labelling standards.
• Develops procedures and policies to streamline the labelling design/development process.
• Communicates effectively with all levels of management, business units (Corporate and International), and possesses a high degree of flexibility/selectivity in prioritizing business units and plant projects to meet established goals.

Qualifications

• BS or BA degree in a technical, scientific, packaging, writing or related discipline.
• Minimum of 5 years of experience in packaging or labeling.
• Desktop Publishing application experience (Adobe Creative Suite and/or MadCap Flare).
• Experience working on international cross-functional teams.
• Working knowledge of US and international medical device regulations.
• Demonstrated ability to influence others (beyond direct reports).
• Demonstrated ability to effectively handle multiple project priorities.
• Excellent organization & prioritization skills.
• Excellent follow-up and documentation skills.