Job Description
The Sr. Labeling Rep will be 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
Key Responsibilities:
• 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 adherence to GDP (Good Documentation Practices). Actively follow up on change requests (e.g., SARS, ECRs) and manage approvers to ensure timely closure
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• Execute labeling verification activities by proofreading labeling against input documents, master mark-up (e.g., redlines) and specification for implementation accuracy and formatting (e.g., layout and typeface) base on labeling process and procedures
• Evaluate routine risks and provide recommendations to resolve issues.
• Update more complex procedures and lead routine process improvement opportunities within scope
• Provide training and coaching to other team members
• Other incidental duties
Minimum Qualifications:
• H.S. Diploma or equivalent and 6 years of related work experience OR
• Associate's Degree or equivalent and 4 years of related work experience
Preferred Skills:
• Good computer skills including usage of MS Office Suite
• Good written and verbal communication skills and interpersonal relationship skills
• Good time management and organizational skills
• Ability to identify process improvement activities
• Able to read, comprehend, write, and speak English
• 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
• Full knowledge of labeling systems and applications (e.g., ECR and PDM processes)
• Strict attention to detail
• Must be able to work in a team environment, including inter-departmental teams and other business units, under general supervision
• Provide feedback in a professional, direct, and tactful manner
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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
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 $49,000 to $66,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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.