Edwards Lifesciences Sr. Specialist, Labeling in Irvine, California
Execute new global content and packaging/labeling artwork in support of new product launches and base business projects in all divisions of Edwards Accountable for ensuring that all work associated with updates or changes to global labeling standards/procedures, training plans and process improvements, routing and approval of assigned labeling deliverables through ECR and PDM processes is carried out in compliance with relevant standards and regulations.
• Identify solutions for complex Clinical, NPD and Sustaining labeling change request requirements and demand planning.
o Lead solution development for labeling projects, which includes providing recommended activities and solution modifications. Guide requestor and cross-functional representatives with definition of labeling design requirements. Establish agreement on content, format and artifact (e.g., IFUs, Labels, Implant Cards, and Operations Manuals) solutions for complex labeling change packages.
o Identify and collaborate with BU on priorities and workflow milestones (e.g., NPD core team member, regulatory changes, acquisitions, site transfers). Develop and maintain an execution plan with target dates for creation of new/revised content and cost-effective labeling solutions. Provide guidance and leadership to identify, manage, and execute alternate strategies to accelerate timetables on critical projects.
• Provide leadership and build consensus on project execution plan for complex and critical labeling change requests.
o Provide guidance, establish consensus within the BU Labeling team on solution details to assure alignment with project plan and deliverables.
o Translate business needs of new and existing labeling artifacts into effective and compliant solutions.
o 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. Assist labeling development team with execution of the proposed workflow. Identify adjustment &/or modifications to design solutions (lead TCA efforts and drive solution refinement with multi-functional teams) to improve efficiency and effectiveness. Partner with team members to ensure label change package execution meets project deliverables.
• Identify and lead process improvement projects (e.g., Kaizen); includes providing proposals and implementing solutions while providing guidance and training as required.
• Lead resolution of SCARs, NCRs, non-conformances and CAPAs (e.g., process owners), apply statistically valid data analysis methods and formal root causes assessment tools and develop corrective actions
• On time completion of training requirements for this position and BU Labeling team. Provide coaching, skill development and transfer of knowledge to team members; create labeling process playbook and provide content training for team members and stakeholders
• Evaluate risks and identify alternatives to resolve critical path issues; draft and implement plans for process improvements while minimizing disruption to daily and production activities.
• Other incidental duties
Five years of labeling, regulatory or documentation experience in a medical/pharmaceutical FDA regulated industry
- Experience with MDR requirements
• Strong computer skills including usage of MS Office Suite; experience with MS Project preferred
• 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 establish grammatical and formatting conventions, templates and style guides
• Strong leadership skills with demonstrated ability to influence change
• Proven success adhering to and leading project schedules and managing projects
• Able to read, comprehend, write, and speak English
• Substantial understanding of domestic and global development and implementation of labeling
• Substantial understanding of medical and/or pharmaceutical regulations and standards
• Substantial knowledge of medical device documentation development activities
• Knowledge of ECR, PDM, and CAPA processes
• Strong computer skills including usage of MS Office Suite
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Good project management skills
• Strong leadership skills and ability to influence change
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• 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.
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.