ultrafocused – Work together to fearlessly uncover new possibilities
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.
- Manages case monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regional/country specific regulations.
- 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.
- Monitor the emergency request inbox during assigned monthly on-rotations and appropriately triage urgent treatment requests, including weekends.
- Self‑motivated and able to work through problems of moderate scope and complexity.
- Knowledge of ICH/GCP.
- Minimal travel may be required.
#LI-CS1 #LI-Remote
The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at [email protected].
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Skills Required
- Two years of experience in healthcare or comparable administrative/operational roles
- Strong organizational skills managing high volume tasks and overlapping deadlines
- Proactive mindset with ability to anticipate needs and move cases forward
- Ability to follow processes and procedures with minimal oversight
- Strong interpersonal skills; ability to build positive working relationships with peers, managers, physicians, and site staff
- Monitor the emergency request inbox during assigned monthly on-rotations and appropriately triage urgent treatment requests, including weekends
- Self-motivated and able to work through problems of moderate scope and complexity
- Knowledge of ICH/GCP
- Willingness to travel minimally as required
Ultragenyx Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Ultragenyx and has not been reviewed or approved by Ultragenyx.
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Healthcare Strength — Benefits begin on the first day with multiple medical plan options alongside dental and vision coverage. Employer-funded HSA contributions and employer-paid mental health support via Spring Health add notable depth to healthcare support.
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Leave & Time Off Breadth — Paid time off is broadened by two fully paid company shutdown weeks in August and December in addition to holidays and baseline vacation. Paid sick time, paid volunteer time, and a substantial paid leave program further expand time-off support.
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Retirement Support — Retirement support includes a 401(k) program with a match on employee contributions and immediate vesting. An employee stock purchase plan discount also strengthens the overall financial rewards package.
Ultragenyx Insights
What We Do
At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.
