Summary

Leadership for labeling project management, strategic and tactical label change planning and forecasting of label changes to ensure the Global Label Management organization meets its performance objectives. The position will lead packaging and artwork strategy and shared label strategy across the product lifecycle. Responsibility to lead cross functional teams and drive alignment for labeling projects including manufacturing, engineering, regulatory and supply chain, among others, to achieve the Perfect Label. Ensures assurance of supply and compliance to content and market requirements for new product launches, safety updates and other core labeling programs.

What are the top 3-5 skills, experience or education required for this position:

1. Project management/leadership ( Any industry PM exp.)

2. Labelling operations/creation of labels experience

3. Written and oral communication skills

4. Problem solving skills

5. Pharma industry experience

Responsibilities:

• Global product leadership for strategic planning and forecasting of label change projects
• Responsibility for accuracy and completeness of the Brief phase within the Artwork Management System and to ensure compliance with regulatory requirements
• Project Management responsibility within the system for Production, Design and Asset workflows
• Lead label change projects and associated deliverables for launches, site transfers, country/area specific changes and other labeling focused projects.
• Lead the periodic formal review process for label change management and develop and report performance metrics within label change execution.

Qualifications:

• Bachelor's Degree in Science, Engineering, Business or Supply Chain and minimum of 5 years' experience in Operations, Regulatory or Quality environment
• Proficiency in English (both written and oral)
• Experience working effectively across different cultures, multiple functional areas and in complex matrix environments
• Excellent written and oral communication skills with all levels of management and personnel.
• Understanding of Regulatory, Quality and Supply Chain aspects of labeling and impact of non-compliance
• Knowledge of applicable regulations and standards affecting Pharmaceutical, Device, Device/Combo Products, specifically regulations and standards affecting the Packaging and Labeling Quality System
• Strong project management skills including stakeholder management

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”