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-bd

Job 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 duties

Minimum 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 industry

Preferred 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 goal