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Project Manager, Drug Post Approval Access - Remote (JP9237)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Project Manager, Drug Post Approval Access - Remote (JP9237)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit: Integrated Access Strategy - Oncology
Duration: 28+ months with likely extensions
Posting Date: 9/30/2021
3 Key Consulting is hiring a Project Manager for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
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.  See day-to-day responsibilities below
Why is the Position Open?
Planned Project.
Top Must-Have Skill Sets:
  • Prior experience managing Post Approval Process.
  • Attention to detail.
  • Ability to coordinate cross-functional teams in different time zones.
Day to Day Responsibilities:
  • Support workstream in finalizing PAA Vendor contract
  • Close collaboration with global R&D to ensure 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 to follow
    • Financial
    • Recruitment rates etc
  • Provide updates to Affiliates
    • 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 to relevant 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 to ensure transferrable learnings are generated for future programs
Employee Value Proposition:
Lots of great visibility and broad experience within the industry
Interview process:
Video Skype Panel Interview
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team
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