Job Description
Evaluate Content for Standardized Labels Across Product Lines and Families
Analyse and implement a consistent approach to template and labelling design/execution in a component content management platform.
Key Responsibilities:
* Create and execute solutions, including 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.
Developments:
* Develop standard label templates and labelling content with the Global Labelling Systems.
* Create and update related Global Labelling Standards, Procedures, Step guides, and Training materials.
Ongoing Tasks:
* Working with different suppliers and vendors to propose improvement opportunities.
* Organising label stocks inventory within global labeling team and with suppliers.
* Providing training and coaching to new labeling designers.
Requirements:
* Bachelor's Degree in a related field.
* Related experience in Labeling.
Prioritised Skills:
* Proven successful project management leadership skills.
* Proven expertise in Microsoft Office Suite and related tools and systems.
* Excellent problem-solving, organisational, 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.
Achievements:
* 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.
Additional Knowledge:
* 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.