Partnership Manager (Pharma)

The Third-Party Partnerships Manager – Expanded Access Programs will play a critical role in ensuring seamless supply models for the distribution of unlicensed pharmaceutical products to global markets, in compliance with country-specific regulations. This role involves establishing, managing, and optimizing partnerships with third parties: wholesalers and distributors, in-country regulatory partners, and local agents to facilitate access to life-saving medications for patients in need.

The successful candidate will act as the primary liaison between internal teams, and external partners, ensuring operational excellence, regulatory adherence, and strong relationship management. This position requires a strong background in the oversight and management of international partner management, including contract execution and performance monitoring. Understanding of supply chain logistics and the complexities of navigating the regulatory pathways of expanded and early access programs is an advantage.

Responsibilities:

Program Strategy and Development

• Design and Implement EAPs: Develop and manage strategic plans for Expanded Access Programs that align with the company’s mission and regulatory guidelines.
• Identify Patient Populations: Collaborate with medical affairs, clinical operations, and regulatory teams to identify patient populations in need of the investigational product.
• Regulatory Compliance: Ensure the EAP is compliant with all relevant local, regional, and international regulatory guidelines (e.g., FDA, EMA, etc.).
• Cross-Functional Collaboration: Work closely with internal teams (e.g., clinical, regulatory, legal, and commercial) to ensure the EAP is aligned with overall business objectives.

 Third-Party Management

• Engage and Manage External Partners: Build and maintain relationships with third-party providers such as distributors, healthcare providers, non-profit organizations, and clinical trial sites.
• Contract Negotiations and Management: Oversee contracts with third-party providers, ensuring favorable terms and adherence to timelines, budget, and service-level agreements (SLAs).
• Vendor Selection and Oversight: Evaluate and select vendors for patient support services, logistics, and other related services, ensuring they meet the program’s standards.
• Third-Party Communications: Act as the primary point of contact for third-party partners involved in the EAP, coordinating efforts and resolving any issues that arise.

Patient and Site Management

• Patient Access and Enrollment: Oversee the identification, screening, and enrollment of patients in the EAP, ensuring fair and transparent processes.
• Clinical Site Coordination: Ensure that healthcare providers and clinical sites have the necessary training, materials, and support to deliver investigational products to patients.
• Compassionate Use Management: Ensure compassionate use requests are processed according to company policies and regulatory requirements, managing the approval and distribution of investigational products.

 Compliance, Documentation, and Reporting

• Regulatory Submissions: Ensure all necessary regulatory approvals (e.g., IND, CTD) are obtained prior to program initiation.
• Adverse Event Reporting: Ensure proper reporting of any adverse events related to the expanded access treatment in accordance with regulatory and company guidelines.
• Program Documentation: Maintain comprehensive records of all program-related activities, including patient enrollment, product distribution, adverse events, and any other required regulatory documentation.
• Audit Readiness: Prepare for and manage audits by regulatory authorities or internal teams to ensure adherence to regulations and company standards.

Data Management and Analysis

• Track EAP Data: Collect and analyze data related to the expanded access program, including patient outcomes, usage rates, adverse events, and compliance metrics.
• Program Performance Monitoring: Use data insights to assess the program’s success and areas for improvement, reporting on key performance indicators (KPIs) to stakeholders.
• Outcome Reporting: Provide regular reports on program status to internal stakeholders, including senior management, legal, and regulatory teams.

Training and Support

• Develop Training Materials: Create and distribute educational materials for healthcare providers, patients, and third-party partners involved in the program.
• Staff Training: Provide training to internal teams on program requirements, regulatory considerations, and best practices for managing third-party relationships in the context of EAPs.
• Ongoing Support: Offer continuous support to healthcare providers, patients, and third-party vendors throughout the program’s lifecycle.

Stakeholder Management

• Internal Stakeholder Engagement: Maintain effective communication with internal stakeholders (e.g., regulatory affairs, clinical operations, legal, medical affairs) to ensure alignment and address any issues that arise.
• External Communications: Manage communications with external stakeholders such as patient advocacy groups, healthcare providers, and regulatory bodies, ensuring transparency and addressing concerns effectively.

 Budget and Resource Management

• Budget Oversight: Manage the budget for the EAP, ensuring proper allocation of resources, and monitoring costs associated with product distribution, patient support, and third-party partnerships.
• Resource Planning: Ensure adequate resources (personnel, product inventory, etc.) are available to support the EAP effectively.

Candidate Requirements:

• 5+ years of experience in pharmaceutical/biotech/medical device industry, with a strong focus on third-party partnerships, patient access programs, or clinical operations.
• Experience specifically in managing Expanded Access Programs (EAP) or Compassionate Use Programs is highly desirable.
• Experience with regulatory processes related to expanded access, compassionate use, or investigational product distribution (e.g., IND, EMA guidelines).
• Experience in cross-functional collaboration with medical affairs, clinical, regulatory, legal, and commercial teams.
• Previous experience in managing third-party vendors and partnerships, including negotiations, performance monitoring, and contract management.

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.