Job Description - Specialist, Labeling - Critical Care (011137)
Specialist, Labeling - Critical Care-011137
The Critical Care labeling business partner will be a labeling representative and subject matter expert (SME) to work with the cross-functional team and business partners. This role will interface with the project team and gather labeling requirements and create labeling strategy and timeline to support project and/or business needs.
The labeling business partner will lead the development of strategic solutions for labeling projects, including recommending and leading activities to resolve various business scenarios involving: legacy systems, country-specific requirements, and product performance updates. Labeling business partner will facilitates the labeling activities to establish labeling content/ requirement, changes, update for product labels, instructions for use (IFU) and operation manuals. This role will engage with and mobilize the cross functional team to resolve production obstacles effectively, be responsible for meeting key labeling objectives, and heavily lead and collaborate on continuous improvement initiatives.
- Leads the development of strategic solutions for labeling projects, including recommending and leading activities to resolve various business scenarios involving: legacy systems, country-specific requirements, and product performance updates
- Leads activities that establish labeling content and instructions for use labeling; including evaluating information input into system to determine necessary content for use in labeling
- Evaluates risks and identifies new alternatives to resolves critical issues and plans approaches for implementing labeling to support the project
- Provides guidance to management in identifying/executing alternate strategies to accelerate timetables for critical projects. Develops and maintains timetables for creating new/revised content and labeling in a cost-effective manner
- Attends project meetings including project prioritization meetings, Operational meetings, etc.
- Bachelor’s degree
- Three years labeling experience, preferably in the following areas: medical/pharmaceutical FDA regulated industry
- Demonstrated skills in decision-making and independent initiative
- Project Management Professional (PMP) Certificate is a plus
- Analytical and communication skills, both oral and written
- Organizational skills, and a self-starter
- Knowledge of medical or pharmaceutical regulations as relating to labeling and documentation
- Ability to produce results
- Ability to function well under pressure and balance day-to-day requirements with special projects
- High level of detailed accuracy
- Skills in Microsoft Word, Excel, PowerPoint, and Outlook
- Good knowledge of project management software tools such as Microsoft Project
Edwards has been advancing the care of the acutely ill for more than 40 years. Starting with the development of Swan-Ganz advanced hemodynamic monitoring devices for measuring cardiovascular performance in high-risk surgical and critically ill patients, Edwards continues to evolve to less-invasive and noninvasive devices to provide valuable hemodynamic insight for an expanded patient population. Edwards has continued to advance hemodynamic monitoring platforms to enable proactive clinical decisions for surgical, anesthesia and critical care clinicians. Edwards is focused on helping clinicians enhance knowledge and standardize practice to improve the quality and efficiency of care. Edwards provides evidence-based programs such as Enhanced Surgical Recovery Program that support the implementation and compliance to protocolized care pathways in the OR and ICU.
Our vascular therapies products, including genuine Fogarty catheters, continue this high standard. Developed and refined in close collaboration with surgeons and interventionalists for over 50 years, Fogarty catheters have been used in millions of procedures worldwide.
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save 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 10,000 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. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.
Primary Location:USA-USA-California - Irvine