Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Manages, monitors, and controls labeling requests from project notification through implementation.                                                                                                      

Perform labelling impact assessment, Create labeling project plan and schedule.

Request, obtain endorsement or agreement from stakeholders, hold accountability to the project plan, and escalate when deliverable dates are at risk or missed.                                                                  

Report status/issues/risks/escalations to project team and management.                                            

Lead labeling project meetings.                                                                                                                      

Facilitate Labeling Input Review (i.e., meeting to review inputs and resolve conflicts between labeling content and labeling specification requirements).                                                                                            

In collaboration with stakeholders, gather project requirements for labeling (including eIFUs).

Gather Inputs from stakeholders and create redline for IFU’s and Labels.                                              Develop and Update Manuals, IFU’s and Labels for the product in scope.                                     

Approve final labeling artwork and/or final labeling specification.                                                                  Coordinate posting of eIFU's.

Coordinate labeling obsolescence (sustaining change only).                                                                        Coordinate with translation vendor for translation of manuals for the applicable languages in scope.            

Coordinate for In Country Reviews (ICR).                                                                                                    Review and approve Labeling Verification plan, Test cases and Report.                                                     

Review and approve executed Labeling Test results.

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

Recruitment Fraud Notice

Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.