Job Information
Edwards Lifesciences Labelling Specialist in Limerick, Ireland
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