Senior Rep, Labeling Jobs

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. For more than 50 years, we have established a remarkable track record around that innovation: Work that enables clinicians around the world to enhance and save lives.
The Sr. Labeling Rep will work with the cross-functional project team to deliver best labeling solutions, drive label and IFU release, and support the implementation of various projects.
Key Responsibilities:

• Update more complex procedures and lead routine process improvement opportunities within scope
• Execute complex label change packages (e.g., ECO, mass updates, redlines, ECR generation and processing, compiling documentation, data entry) within and across all business units/sites with limited to no direction. Summarize and capture change intent accurately within quality system (e.g., ECR) in adherance to GDP (Good Documentation Practices). Actively follow up on change requests (e.g., SARS, ECRs) and manage approvers to ensure timely closure
• Provide training and coaching to other team members
• Evaluate routine risks and provide recommendations to resolve issues.
• Other incidental duties

Minimum Qualifications:

• Associate's Degree with 4 years of related experience OR H.S. Diploma with 6 years of related experience required

Preferred Qualifications

• Able to read, comprehend, write, and speak English
• Ability to identify process improvement activities
• Good time management and organizational skills
• Must be able to work in a team environment, including inter-departmental teams and other business units, under general supervision
• Full knowledge of labeling systems and applications (e.g., ECR and PDM processes)
• Good written and verbal communication skills and interpersonal relationship skills
• Full knowledge and understanding of policies, procedures, and requirements as it relates to task execution within labeling operations
• Good knowledge of labeling requirements across business units
• Good computer skills including usage of MS Office Suite
• Provide feedback in a professional, direct, and tactful manner
• Strict attention to detail

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California, the base pay range for this position is $47,000 to $65,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
About Edwards Lifesciences
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 13,000 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.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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