Sr Specialist, Labeling Design
Design, develop, and update global labeling documents to include product labels, instructions for use (IFUs), patient implant cards, specifications, and technical documentation. Job duties:
- Develop strategies for continuous improvement of the Labeling program and procedures.
- Conduct investigations and troubleshooting to address labeling non-conformances and document appropriately per the quality system.
- Provide advice or consultancy to other teams with respect to labeling implementation processes.
- Design, develop, and implement changes to new and existing product labels and instructions for use (IFUs) using labeling and design software.
- Collaborate with labeling change request initiators to understand requirements, design solutions, timelines, and deliverables. Develop standardized and optimized label templates and identify issues associated with design.
- Ensure labeling compliance with quality management system (QMS), regulatory requirements and guidelines, standard operating procedures, and work instructions.
- Effectively collaborate with cross-functional groups and stakeholders for successful implementation of labeling designs and changes.
- Coordinate with suppliers and vendors for outsourced printed products and translated materials.
- Conduct investigations, root cause analyses, and the development of corrective actions to address labeling non-conformances. Lead activities to implement corrective actions.
- Complete labeling initiatives by collaborating with individuals from functional groups and providing solutions to meet objectives.
- Assign tasks and provide guidance, mentoring direction to the labeling group and contractors regarding labeling workflow, project status, and priorities.
- Communicate anticipated assignment completion dates to affected coworkers. Meet timeline commitments with minimal supervision.
- Perform other responsibilities as assigned.
- Bachelor’s degree in related field or equivalent combination of education and experience.
- A minimum of seven (7) years of experience in a medical device or pharmaceutical FDA regulated environment producing technical documentation and in labeling and digital design software platforms, including labeling database management.
- High level of attention to detail and sustained focus.
- Project management skills and experience.
- Strong computer skills in Adobe Suite, Microsoft Office, project management software and databases.
- Excellent problem-solving, organizational, analytical, and critical thinking skills.
- Ability to work in a cross-functional environment while building positive internal/external working relationships.
- Excellent written and verbal communication skills.
- Extensive knowledge and efficient use of Enterprise Label Management software (e.g., Teklynx Codesoft, Loftware Spectrum, PRISYM 360, etc.). Extensive knowledge of Adobe Creative Suite (e.g., Illustrator, InDesign, Photoshop, etc.).
- Moderate knowledge of Product Lifecycle Management software (e.g., Windchill, Agile, Teamcenter).
- Ability to create CAD drawings and perform intermediate level tasks in SOLIDWORKS.
- Knowledge of FDA and global regulations as it relates to labeling requirements and documentation.
- Understanding of domestic and global labeling implementation.