Top 3 Must Have Skill Sets:
- Process document technical authoring capabilities
- FDA submission experience
- Insight Manager Registrations (IMR) and/or Veeva experience
- Ability to compare content manually or using Adobe Compare software
- Intermediate to advanced Microsoft Office, including visio, excel, and SharePoint skills
Previous Amgen experience (not required, but preferred)
Day to Day Responsibilities:
Title: Regulatory Project Coordinator (RPC)
- Perform Abbreviated reviews by manually comparing content or using Adobe Compare software to discern allowable differences were made from previous version of content for a label change via point of Important Safety Information (ISI) reference document.
- Assist in authoring process documentation
- Perform FDA communications archiving
- Miscellaneous data hygiene projects to collect or update metadata in Veeva system of record
- Product team support for process documentation authoring/updates in MS Word, Visio diagramming, Power Point slides creation and excel (vlookup and Pivot tables)
Assist US Promotion Regulatory Representatives to support US Promotion regulatory activities (e.g. Abbreviated Reviews and system updates for label changes, Regulatory Information Management (RIM) and other process documentation authoring support, Veeva data entry and collection)
Create and maintain product regulatory history documents through IMR/Veeva and appropriately archive all regulatory documents and agency communications per process.
Coordinate QC of regulatory documentation (e.g. Request for Advisory Comments and other FDA communications)
Administrative projects in support of Material Compliance Managers and Operations staff during project period. Create PowerPoint, Visio, manipulate data in Excel spreadsheets and author/update MSWord documents.
"This posting is for Contingent Worker, not an FTE"