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Associate Specialist, Labeling

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: November 18, 2021

Job Description:

Translate business needs and requirements for labeling change packages. Key Responsibilities:--- Determine labeling requirements for routine labeling change packages (e.g., MDRs, sustaining changes label/IFU content, CMS migration) by translating business needs for existing labeling documentation (e.g., IFU, product labeling, operations manual) and prioritzing execution workflow. Partner with team members to ensure label change package execution meets project deliverables.--- Collaborate with business unit stakeholders in the development of solutions for labeling projects.--- Follow and maintain timetables for creating new/revised content and labeling in a cost-effective manner--- Evaluate routine risks and provide recommendations to resolve issues.--- Participate in process improvement projects--- Other incidental duties:Participate in risk assessements to support NCR and CAPA activities. Education and Experience:Bachelor's Degree 1 year years experience of related experience Required andworking in a medical/pharmaceutical FDA regulated industry Preferred. Additional Skills:--- Good computer skills including usage of MS Office Suite--- Excellent written and verbal communication skills and interpersonal relationship skills--- Ability to follow established grammatical and formatting conventions, templates and style guides--- Able to read, comprehend, write, and speak English--- Moderate understanding of domestic development and implementation of labeling--- Basic understanding of medical and/or pharmaceutical regulations and standards--- Basic knowledge of medical device documentation development activities--- Knowledge of ECR and Ignite processes--- Good computer skills including usage of MS Office Suite--- Basic problem-solving, organizational, analytical and critical thinking skills--- Strict attention to detail--- Work is performed independently on sections of projects and/or lines of work and reviewed for accuracy and soundness--- Participates in arranging own activities in accomplishing objectives--- Abilty to evaluate change package and make decisions on resource consumption--- Contributes to the completion of sections of organizational projects and goals Errors in judgment or failure to achieve results may require some expenditures of resources to rectify--- Ability to build stable working relationships internally--- Develops solutions to a variety of problems of basic scope and complexity--- Participate in process improvements--- 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. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.. 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 or have a valid religious or medical exemption from being vaccinated.

Keywords: Edwards Lifesciences Gruppe, Irvine , Associate Specialist, Labeling, Other , Irvine, California

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