EAP Program Manager - US

Objective:

As the Durbin 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. The role has line management responsibility for 3 Customer Service Advisors who are responsible for physician engagements, registrations and order processing.

Specific Job 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 a close working relationship with clinical program management team at RRD to delivery US Expanded Access Programs in line with the FDA Expanded Access Framework
• Line management responsibility for 3 US based Customer Service Advisors, overseeing day to day duties of customer service, HCP registrations, order processing and tracking
• 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

Essential:

• More than 7 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

Desirable:

• 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

Uniphar Background

Uniphar Group is a rapidly expanding diversified healthcare services business with a global footprint and a proud heritage in Ireland.  Since Uniphar became a publicly listed company in 2019, the Group has grown organically and through a series of strategic acquisitions, which continue to strengthen Uniphar’s international reach. With a workforce of more than 3,000 spread across Ireland, United Kingdom, Mainland Europe, MENA and the USA, Uniphar is a trusted global partner to pharma and medtech manufacturers, working to improve patient access to medicines and treatments around the world.

Uniphar provides outsourced and specialised services to its clients, leveraging the strong relationships with 200+ of the world’s best known pharmaco-medical manufacturers across multiple geographies, enabled by our cutting-edge digital technology and our expert teams. Uniphar is organised into three key divisions: Uniphar Supply Chain & Retail, Uniphar Medtech and Uniphar Pharma

Uniphar Pharma

Pharma is a global division operating across US, Europe, APAC and MENA, bringing a range of pharma services to manufacturers across the product life cycle. We leverage this platform to provide unlicensed medicines, or medicines that are otherwise difficult to source. In addition, we commercialise launch and established brands to HCPs on behalf of pharmaceutical clients across the globe. The core to this division is providing equitable access to medicines globally.

Culture at Uniphar

From our leadership team and across all of our divisions, Uniphar lives and breathes four key culture pillars:

1.We have a People First approach, we do the right thing and take a stand for our people.

2.We foster a strong Entrepreneurial Spirit where Adaptability, Commitment & Resilience is embodied in our way of working.

3.We have a Common Purpose that connects our diversified businesses and people.

4. Finally, Trust is at the heart of how we operate.

Check out our EVP to see why you should join us:

https://uniphar.euwest01.umbraco.io/media/44rfphln/uniphar-pharma_evp_2024_pdf_v2.pdf

How we’d like to work together

As we are a global team, there is flexibility to be based in one of Uniphar’s offices or work from home.  There may be a need for face to face meetings in other locations, as needed.  There may also some flexibility required in order to interact with colleagues or clients in their time zones (i.e. it’s not a ‘9 to 5’ type of job).  In return, you will be joining an environment that understands how inter-twined work and life have become - and both the benefits and challenges that brings - and therefore offers a flexible, progressive way of supporting it through our Hybrid Working philosophy.

Please note that Uniphar is an equal-opportunity employer; we do not discriminate and welcome all responses.