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Project Manager

Thousand Oaks, CA
Top 3 Must Have Skill Sets:    
  • Prior experience managing Post Approval Process
  • Attention tdetail
  • Ability tcoordinate cross-functional teams in different time zones
  • experience managing a post approval access program, experience managing an expanded access program (sometimes referred tas early access program), OR experience managing a compassionate drug use program
Day Day Responsibilities:    
  • Tasks for PAA Project Manager:
  • Support workstream in finalizing PAA Vendor contract
  • Close collaboration with global R&D tensure smooth transition strategy and process from EAP in line with global and local compliance rules
  • Provide updates on # of subjects within the program
  • Reporting, consolidation, budget tracking, escalation of events that exceed overall budget
  • Interface and collaborating with PAA vendor on all steps of the program
  • point of contact and liaison with country, global medical for approval on a medical ground for a patient, when a request escalated.
  • Interface for all Metrics
  • Interface between country and PAA Vendor, for any local inquiries (& vice versa)
  • Track & update any metrics that Access would like tfollow
  • Financial
  • Recruitment rates etc
  • Provide updates tAffiliates
  • Reporting
  • Escalation contact point for exception cases
  • point of contact and liaison with country
  • Day-to-day operation of the program
  • Resolve operational supply challenges, issues, and any other points
  • Providing regular updates and interface trelevant stakeholders from various functions (Supply & Operations, IAS team, Medical, Finance)
  • Coordination and documentation of MoM, and action items (including tracking and follow up)
  • Knowledge management and document storage tensure transferrable learnings are generated for future programs
The project manager will be the single point of contact in interactions between local markets and the Vendor for post approval access (PAA) execution. The successful candidate will lead and drive the PAA execution and is responsible for the day-to-day operation of the PAA programs around the globe.
 "This posting is for Contingent Worker, not an FTE"

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