Senior Specialist, Labeling (Localization), Critical Care

For over 50 years, the Critical Care business within Edwards has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we’re committed to creating a world where every patient who should be monitored will be monitored with smart technology.If you're eager to contribute your expertise and commitment to Critical Care’s mission, we invite you to explore these career opportunities. Those who join us or continue their current journey within Critical Care will play their own part in improving the quality of care and outcomes for millions of patients around the world.On June 3, 2024, Edwards announced that it had entered into a definitive agreement to sell its Critical Care product group to BD (Becton, Dickinson and Company) (NYSE: BDX). It remains business as usual at Edwards until the transaction closes. More information on Edwards’ announcement about the acquisition can be found here: https://www.edwards.com/newsroom/news/2024-06-03-edwards-lifesciences-to-sell-critical-care-to-bdJob Description:The Sr. Labeling Specialist, Localization will partner with vendors and internal stakeholders on translation projects to ensure timely execution of translation projects. This includes internal and external communication, project hand off and delivery, identifying translation issues and determining resolutions, translation strategy, forecast, metric and localization spend tracking, creating PO’s and management of other localization related documents and procedures. The Sr. Labeling Specialist, Localization will support 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.Key Responsibilities: Partner with vendors on translation projects, including internal and external communication, to ensure timely execution. Identify translations issues and determine resolutions. Determine and discern translation requirements for designated translation projects to/from vendor via TMS or CMS Perform root cause and trending analysis on translation issues to facilitate process improvements Run Localization QC tool post-delivery and provide feedback to the vendor regarding possible translation issues. Collect localization forecasting for the translation vendors. Track metrics and localization spend, create POs and other contract related documents. Initiate root cause investigations for translation vendor driven non-conformances and CAPA/SCAR investigations and ownership. Other incidental dutiesMinimum Qualification: Bachelor's Degree plus five (5) years of related experience in a medical/pharmaceutical/FDA regulated industry OR Master’s Degree plus three (3) years of related experience in a medical/pharmaceutical/FDA regulated industryPreferred Skills: Good computer skills including usage of MS Office Suite Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills Ability to establish grammatical and formatting conventions, templates and style guides Good leadership skills Experience managing tasks of projects Able to read, comprehend, write, and speak English Moderate understanding of domestic and global development and implementation of labeling Moderate understanding of medical and/or pharmaceutical regulations and standards Moderate knowledge of medical device documentation development activities Knowledge of ECR and PDM processes Good computer skills including usage of MS Office Suite Good problem-solving, organizational, analytical and critical thinking skills Basic project management skills Strict attention to detail Work is performed independently on more complex projects and/or lines of work and reviewed for accuracy and soundness Participates in determining objectives of assignment; arranges own activities in accomplishing objectives Ability to evaluate change package and make decisions on resource consumption Contributes to the completion of more complex organizational projects and goals Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify Ability to build productive internal/external working relationships Develops solutions to a variety of problems of moderate scope and complexity Contributes to 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.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 $88,000 to $124,000 (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 RequirementEdwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.