Execute new global content and packaging/labeling artwork in support of assigned Business Unit for new product launches and base business projects. Accountable for ensuring that all work and deliverables associated with labeling updates or changes adhere to regulatory, in-country and Edwards labeling standards/procedures. Assure that labeling deliverables are complete and on time, meet requirements, and routed for approval and release through the Edwards Quality Management System/s and are in compliance with relevant standards and regulations.
Identify solutions for the Clinical, NPD and Sustaining labeling change request requirements:
- Provide definition to the requestor and cross-functional representatives with labeling design requirements while establishing agreement on content, format and artifact (e.g., IFUs, Labels, Implant Cards, and Operations Manuals) solutions for moderately complex labeling change packages.
- Review workflow expectations and milestones to achieve results to ensure alignment with business strategy, comply with labeling quality systems and meet customer expectations with ability to reach consensus on priorities and target completion dates.
Identify, evaluate, make recommendations and execute labeling change; request tasks to assure alignment with project solution and requested target dates:
- Provide recommendations and regular report out on activities and issues resolution of various business scenarios. Prepare, review and approve labeling intake documentation. Provide guidance to labeling team on identification and execution of typical solutions with accelerate timetables for critical projects.
- Develop and maintain timetables for creation of new and revisions to existing labeling content and format in a cost-effective manner. Partner with team members to ensure label change package execution aligns with project deliverables.
Lead sections of process improvement projects and propose solutions. Identify and define gaps, revise verbiage to clarify, improve/enhance and/or correct relevant procedures and provide guidance and training as needed.
Provide support to resolve SCARs, NCRs, non-conformances and CAPAs (e.g., process owners). Apply statistically based data research and analysis methods and techniques to identify root causes and corrective actions.
On time completion of training requirements for this position, assist with knowledge and skill transfer to team members. Assist with creation and maintenance labeling process playbook and provide content and format training for team members and stakeholders.
Evaluate and assess risks, identify options to resolve critical path issues
Other incidental duties
- Bachelor's Degree required
- Three years of Labeling related experience in a medical/pharmaceutical and/or regulated industry
- Good computer skills including usage of MS Office Suite
- Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills
- Ability to establish grammatical and formatting conventions, templates and style guides
- Good leadership skills
- Experience managing tasks of projects
- Able to read, comprehend, write, and speak English
- Moderate understanding of domestic and global development and implementation of labeling
- Moderate understanding of medical and/or pharmaceutical regulations and standards
- Moderate knowledge of medical device documentation development activities
- Knowledge of ECR and PDM processes
- Good problem-solving, organizational, analytical and critical thinking skills
- Basic project management skills
- Strict attention to detail
- Ability to build productive internal/external working relationships
- Adhere to all EHS rules and requirements 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
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.