Expanded Access Program Manager
Responsible for the successful delivery of assigned programs from award through to close‑out, ensuring all client expectations are met or exceeded. Acting as the primary point of contact for pharmaceutical and biotech partners, you will lead cross‑functional teams to design, implement, and manage Expanded Access and exclusive distribution programs in line with global regulatory and GDP requirements. You will oversee all aspects of program operations, including contract management, onboarding of clients and products, process development, vendor oversight, performance tracking, and client reporting. This role requires strong leadership, strategic insight into drug development lifecycles, and the ability to identify opportunities to expand services within existing accounts.
Main Responsibilities
Entire life‑cycle program delivery from program award to close out.
Full accountability for success of the program in accordance with client expectations.
Primary point of contact for client companies and overall accountability for program delivery.
Lead a cross‑functional program team comprising stakeholders across Uniphar Group for the design, implementation and delivery of EAPs.
Ensure all necessary contracts and agreements (MSA, SOW, QTA, DPA, SDA and others as required) are in place upon award of the program.
Manage deliverables and Key Performance Indicators for the assigned program.
Onboard the client, their manufacturer and product(s) within relevant Uniphar Group companies.
Advocate for assigned clients within Uniphar Group to ensure best‑in‑class service throughout the program life cycle.
Collaborate with internal teams (regulatory, supply chain, quality and technical) to implement client requirements in line with global regulatory requirements.
Design, write and implement program‑specific processes and ensure team compliance.
Manage third‑party vendors responsible for delivering services for client programs.
Maintain client communication per agreed program plan, including weekly and monthly meetings and ad‑hoc updates.
Manage scope changes through assessment of contractual and operational implications and progression with internal cross‑functional support.
Ensure all program reporting requirements are met at agreed times and frequencies.
Deliver Key Performance Indicators, including budgetary targets and account relationship development objectives.
Understand client asset plans within drug development and launch to predict, plan and execute transitions.
Identify opportunities for new business development from existing clients.
Carry out relevant GDP SOPs as instructed by the RP of the Company.
Key Requirements
Leadership & Project Management: Proven ability to lead programs and manage complex projects.
Pharma/Biotech Knowledge: Understanding of drug development lifecycles, regulatory requirements, and GDP (Good Distribution Practice).
Client Relationship Management: Skilled at serving as the main point of contact, building trust, managing expectations, and identifying growth opportunities.
Operational Expertise: Experience in contract management, onboarding products/clients, process design, vendor oversight, and performance tracking.
Regulatory & Quality Awareness: Ensure adherence to global regulations, quality standards, and internal Standard Operating Procedures (SOPs).
Communication & Reporting: Excellent written and verbal communication skills; able to run client meetings, manage scope changes, and deliver clear reporting.
Strategic Mindset: Capable of seeing the bigger picture, anticipating client needs, and aligning programs with long‑term goals.
How We’d Like To Work Together
As a global team, there is flexibility to be based in one of Uniphar’s offices or work from home. Face‑to‑face meetings may be required in other locations, as needed. Some flexibility is necessary to interact with colleagues or clients in their time zones. We offer a flexible, progressive hybrid working philosophy.
Equal Opportunity Employer
Please note that Uniphar is an equal‑opportunity employer; we do not discriminate and welcome all responses.
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