In this role, the main focus is ensuring Patient Support Program Compliance. As a part of this, I work collaboratively with internal and external resources, provide key input and output to meet project deadlines, and support the patient support team to quickly address and resolve issues.

This role focused on Patient Support Training, Quality & Complaince, and systems management. Through this experience I was able to develop skills related to maintaining materials through Veeva and in partnership with Medical Legal and Regulatory Subject Matter Experts to ensure that the materials held current industry standards. I was able to provide support to the team regarding matters of Quality and Complaince and sought clarification, provided support, and coaching as needed. Additional focus surrounded FDA Inspection Readiness, preparation and participation in internal audits and FDA inspection.Also participated in validated and non validated system releases, end user testing, Deviation and CAPA management, as well as vendor management and cross functional collaboration of the releases.

While in this role, I supported callers, patients, healthcare providers, and healthcare settings with navigating treatment logistics while ensure complaince to the REMS Program. Experience with Annual REMS Assessment, cross-departmental collaboration, while providing analysis of data in partnership with the internal and external team. Additional maintenance of public facing materials related to the Patient Support Program.

Primarily acted as a case manager, assisting with logisitics surrounding treatment. Additionally supported the REMS program by providing a high level of compliance to protocols and procedures. Participated in and user software testing, proof-reading, and launch readiness activities. Supported the Program team by providing rapid high quality reviews of information including edits, and content creation. Facilitated training on Patient Support processes.