Project Coordinator, Expanded Access Programs

Temporary work opportunities align well with professionals seeking career flexibility and non-traditional ways of working, while being driven to deliver exceptional results in high-profile environments. Magnit Direct Source is a service offered by Magnit Global that connects top talent directly to industry-leading clients with flexible temporary assignments across a variety of impactful projects. BeOne Medicines is creating the world’s next generation cancer treatments. As a global oncology company focused on uniting against cancer, BeOne Medicines brings together passional professionals dedicated to making a difference for patients worldwide. This opportunity is part of BeOne’s Contingent Workforce Program in partnership with Magnit Global.

As a temporary contractor supporting BeOne Medicines, you will be employed by our contingent talent partner, Magnit Global, who manages BeOne’s contingent and temporary workforce. Magnit Global is a leading workforce solutions and technology company specializing in contingent workforce management. Magnit partners with organizations across industries including healthcare, pharmaceuticals, research and development, consumer electronics and more. Magnit offers a comprehensive benefits package, including medical, dental, vision, and 401(k).

Magnit is a leading, global professional services and technology company and a certified "Great Place to Work". We have been a leader in contingent workforce management since 1991 and work with leading Fortune 500 companies and other large organizations across numerous verticals including consumer electronics, research and development, pharmaceuticals, health services, and many more. Magnit offers benefits including medical, dental, vision, and 401(k).

General Description

Aligned with BeOne's commitment to provide access for cancer patients, the Coordinator of Expanded Access Programs (EAP) will play a pivotal role in supporting medical affairs initiatives, including compassionate use, pre-reimbursement, and post-trial supply programs for patients with dire need. This role involves coordinating global medicine access programs to ensure effective and compliant operational delivery.

Responsibilities include executing all the operational aspects of Expanded Access Programs (EAPs). Key tasks include handling day-to-day operations and individual medicine requests to ensure seamless integration with Global Medical Affairs services and alignment with best practices and compliance standards. Additional responsibilities include supporting program implementations, including contracting, reporting, documentation, technical administration of system platforms, programming, tracking project progress, optimizing processes, responding to cross-functional team needs, and managing operations with third parties. This role demands analytical, project coordination, communication, and interpersonal skills to fulfill these duties effectively.

The role covers a broad therapeutic portfolio of projects, including Hemato-Oncology and Solid Tumors, with tasks that may span specific regions or require international collaboration.

Essential Functions Of The Job

• Day-to-Day Operations: Manage individual EAP requests, liaise with medical reviewers, distribution vendors, and operational Leads. Contracting, administration, and technical support for systems and platforms. Maintain records, documentation, and perform cross-functional reporting duties.
• Project Coordination: support management of project risks, performance, and ensure timely reporting on project status and deliverables. Facilitate the execution of access programs across geographies; support the implementation for the Lead and the Operational Team through reviews and ad-hoc analyses.
• Process Maintenance: Ensure compliance with SOPs and identify process improvements. Includes evaluating platform/system performance, customizing, and implementing changes. Collaborate with Medical Operations Leads and Quality Assurance to review required documentation, ensuring alignment with quality standards and compliance requirements
• Cross-functional Collaboration: Partner with clinical/commercial supply, safety, quality, finance, procurement, legal, regulatory, compliance, privacy, operations, and other teams to address any operational needs.
• Vendor Coordination: Supporting the setup, reviews, audits, and management of various documentation, including purchase orders, ensuring high-quality performance, and coordinating the resolution of any issues.
  
  

Education/Experience Required

• Detail-oriented and diligent, ensuring operational excellence.
• Proficiency in IT, including familiarity with automated platforms (such as CyberGrants), project management software (like SmartSheet), Microsoft Office products (including Power BI), and platforms such as Ariba, Agiloft, SAP, and Veeva.
• Strong skills in project coordination and organization, with the capability to analyze, monitor, and support document and data management.
• A strong affinity for process analysis and improvements.
• Hands-on experience in Expanded Access, Clinical Operations, or related fields, complemented by an understanding of cross-functional relations, like regulatory, supply chain, quality, and pharmacovigilance.
• Proactive and reliable, with excellent time management skills.
• Ability to thrive in a fast-paced environment, effectively prioritize tasks, and make sound judgments independently.
• Solid verbal and written communication skills, a high level of cultural adaptability, coupled with strong interpersonal skills to build trust.
• A minimum of 2 years of experience in the healthcare industry, with a preference for roles in Medical Affairs, R&D, Clinical Operations, or with CROs/vendors.
  
  

This is the pay range that Magnit reasonably expects to pay for this position: $31.86/hour - $42.49/hour

Benefits: Medical, Dental, Vision, 401K