Note: The job is a remote job and is open to candidates in USA. Uniphar Group is a rapidly expanding diversified healthcare services business with a global footprint. They are seeking a US Expanded Access Program Manager to lead US Expanded Access programs and co-manage global programs, ensuring program alignment and effective client communication.
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
- Excellent written and verbal communications skills, demonstrated strong presentation skills
Skills
- 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
- Will have a good working knowledge of US Clinical Trial legislation, working knowledge of US Expanded Access regulations would be an advantage
- 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
- Excellent written and verbal communications skills, demonstrated strong presentation skills
- 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
Benefits
- Remote
- Flexibility to be based in one of Uniphar’s offices or work from home
- Flexible, progressive way of supporting it through our Hybrid Working philosophy
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