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Evaluate content to establish standardized labels across product lines and families. Analyze and implement a consistent approach to template and labeling 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 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 labeling content with the Global Labelling Systems.
* Create and update related Global Labelling Standards, Procedures, Step guides, and Training materials.
* Other incidental duties: working with different suppliers and vendors to propose improvement opportunities, organizing label stocks inventory within the 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 standardized/harmonized 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 relation 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 the environment and prevention of pollution under their span of influence/control.
About Us
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America, and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
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