Early Access Operations Specialist

Role Description

The Early Access Operations Specialist provides critical operational and administrative support for global Managed Access (MA) programs— including Expanded Access and Compassionate Use. This role supports early access requests to investigational treatment for patients with serious or life-threatening conditions. You will collaborate closely with study sites, internal partners, and external vendors to maintain compliant, efficient, and patient-focused operations.

Work Model: Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

• Learn and track regulatory approval pathways for all cases; ensure approvals are collected, up to date, and compliant.
• Maintain audit-ready documentation in accordance with industry standards.
• File study documents in designated systems (e.g., electronic Trial Master File), maintain essential document lists, and participate in TMF completeness reviews.
• Initiate and maintain MA/IST contracts and amendments.
• Coordinate drug supply requests and collaborate with distribution vendors and the vendor manager to monitor shipments, resolve issues, and ensure uninterrupted supply.
• Proactively identify risks and collaborate with peers and senior team members to mitigate them.
• Adhere to departmental processes and high standards of organization and documentation.
• Manage case monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regional/country specific regulations.

Qualifications

• Two years of experience in healthcare or comparable administrative/operational roles with demonstrated adaptability.
• Strong organizational skills with the ability to manage a high volume of small- to medium-scope tasks and overlapping deadlines.
• Proactive mindset with the ability to anticipate needs and move cases forward.
• Ability to follow processes and procedures with minimal oversight.
• Strong interpersonal skills and the ability to build positive working relationships with peers, managers, physicians, and site staff.
• Self-motivated and able to work through problems of moderate scope and complexity.
• Knowledge of ICH/GCP.
• Minimal travel may be required.

Requirements

• Monitor the emergency request inbox during assigned monthly on-rotations and appropriately triage urgent treatment requests, including weekends.

Benefits

• Generous vacation time and public holidays observed by the company.
• Volunteer days.
• Long term incentive and Employee stock purchase plans or equivalent offerings.
• Employee wellbeing benefits.
• Fitness reimbursement.
• Tuition sponsoring.
• Professional development plans.
• Benefits vary by region and country.