Labelling Specialist

Job Description

Evaluate content to establish standardised labels across product lines and families. Analyse and implement a consistent approach to template and labelling design/execution in a component content management platform.
How Will You Make An Impact?

• Create and execute solutions; includes content and format analysis of existing for label designs.
• Evaluate risk assessment and proposed solutions based on redlines. Identify issues and risks associated with proposed design. Apply technical expertise and perspective to simplify proposed labeling designs. Identify, define and implement process improvements to enhance solutions.
• Collaborate with Labelling Specialist and change initiator to refine solution requirements, provide innovation and cost-effective design solutions in a timely manner.
• Develop standard label templates and labelling content with the Global Labelling Systems.
• Create and updates to related Global Labelling Standards, Procedures, Step guides, and Training materials.
• Other incidental duties: working with different suppliers and vendors to propose improvement opportunities, organising label stocks inventory within global labeling team and with suppliers. Provide training and coaching to new labeling designers

What You Will Need?

• Bachelor's Degree in a related field
• Related experience in Labeling Required

Additional Skills:

• Experience working in a regulated industry preferred
• Proven successful project management leadership skills
• Proven expertise in Microsoft Office Suite and related tools and systems
• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Ability to listen to the customer’s requirements, desires and concerns, and then determining whether to recommend standardised/harmonised solutions or possibly customizing a path forward, given a variety of problems of moderate scope and complexity.
• Ability to build productive relationships, influence others and deliver effectively in ambiguous situations
• Good leadership skills
• Experience managing tasks of projects
• Moderate understanding of domestic and global development and implementation of labeling
• Moderate understanding of medical and/or pharmaceutical regulations and standards
• Moderate knowledge of Edwards standards and FDA regulations in relations to labeling and documentation
• Moderate knowledge of medical device documentation development activities
• Knowledge of ECR and PDM processes
• Strict attention to detail
• Ability to build productive internal/external working relationships
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control