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Global Managed Access Project Manager
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About the Job
Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.
Main Responsibilities
The Global Managed Access Project Manager is responsible for the coordination, implementation, and oversight
of global Managed Access activities. Responsibilities include, but are not limited to, the following:
Strategy & Program Design
• For any new product or indication (client development, new acquisition, or new licensing agreement), coordinate
the Managed Access strategy with internal stakeholders (global and local medical affairs, supply chain,
distribution, legal, market access, regulatory, pharmacovigilance, ethics, commercial, etc.).
• In line with the endorsed Client Managed Access strategy by product/indication, participate in the design of
Managed Access operational aspects.
Documentation & Compliance
• Develop, by product/indication, all Managed Access documentation (e.g. patient access form, order form,
informed consent form, HCP responsibilities).
• Ensure the electronic Document Management System (eDMS) for global Managed Access is kept up to date by
uploading and completing all required documentation and information, including safety-supporting evidence.
• Conduct regular quality reviews of global Managed Access documentation within the eDMS.
• Ensure all documentation and information are complete prior to closing global Managed Access programs.
Project Management & Governance
• Be responsible for global Managed Access plans, including timelines and budget.
• Monitor progress of global Managed Access programs against established timelines, budget, and deliverables;
escalate issues as needed and provide regular updates to internal stakeholders.
• Provide monthly status and performance updates of global Managed Access activities in the eDMS.
• Manage cross-functional activities across Client departments from program inception to completion.
Vendor & Stakeholder Management
• Be responsible for procurement activities related to global Managed Access vendor selection and contracting.
• Manage day-to-day operational relationships with global Managed Access vendors to ensure successful
execution and adherence to service level agreements.
• Liaise with internal stakeholders to ensure company strategy, targets, and standards are met.
Support, Training & Continuous Improvement
• Provide support to Managed Access initiatives and programs handled by affiliates.
• Support the Managed Access Director during audits and inspections related to Managed Access.
• Participate with the Managed Access Director in the training of Client employees on the Client Product Access
Request process.
• Contribute to the continuous improvement of Managed Access processes and documentation.
Requirements
About You
At Excelya, taking audacious steps is encouraged, so we're looking for individuals who are ready to grow with us and share our values.
- Experience: Proven ability to thrive in collaborative, fast-moving environments
- Skills: Strong project management, communication, and organizational skills with an emphasis on detail and quality. Knowledge of clinical trial processes and regulatory requirements is essential.
- Education: Degree in Life Sciences, Pharmacy, or a related field.
- Languages: Fluency in French and English.
Benefits
Why Join Us?
At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
Here's what makes us unique.
We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's leading mid-size CRO with the best employee experience. Our one-stop provider service model offering full-service, functional service provider, and consulting enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.
Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.
