EAP Program Manager - US

Uniphar Group•North Carolina, NC

7d•Remote

About The Position

As the Uniphar Expanded Access Team continues to grow to manage our expanding client base, we are looking for a US Expanded Access Program manager. As part of the global Expanded Access team, you will lead on all US Expanded Access programs as well as co-manage global programs where US program management is required.

Requirements

3- 5 years’ experience within the field of Pharma, Biotech or CRO
More than 3 years experience in an external or client facing project management role
Good working knowledge of US Clinical Trial legislation
Experienced in client or external interactions and confident in leading conversations at all levels
Excellent organizational skills required with the ability to handle multiple priorities and meet deadlines.
Educated to degree level, or equivalent in life sciences discipline

Nice To Haves

Working knowledge of US Expanded Access regulations would be an advantage
Prior experience of working on global Expanded Access Programs (e.g., Early Access, Compassionate Use, Named Patient Supply)
Experience of regulations governing clinical trials and patient data collection

Responsibilities

Lead point of contact for clients with US domestic Expanded Access projects: organization and hosting of weekly meetings, project planning and ongoing communications both internally and externally
Cross functional collaboration with the global EAP team to ensure program alignment for global programs and streamlined client communications
Oversight of program delivery and tracking of performance vs KPI metrics
Cross functional collaboration with the US operational teams to ensure that operating functions are set-up for program delivery and in line with program requirements as programs go live
Day to day liaison with client teams to provide updates, discuss ongoing site and patient registrations
Proactively recognize risks within the program delivery model and work with internal and client teams to find resolutions and solutions
Develop and maintain strong relationships with regulatory for programs that operate outside of the USA to build clear picture of supply chain flows and documentation requirements
Reporting and forecasting for each program to anticipate and account for patient enrollments, orders and shipments