Why Join Us?
Be a hero for our rare disease patients
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.
Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.
If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.
Position Summary:
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.
Requirements:
- 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
Full Time employees across the globe enjoy a range of benefits, including, but not limited to:
· 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
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.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to
: [email protected]. 