Early Access Operations Specialist

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $82.2k - $101.5k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

⚙️ Operations

🚫👨‍🎓 No degree required

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Ultragenyx

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2010

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Ultragenyx is a biopharmaceutical company dedicated to transforming the lives of individuals with rare and ultrarare genetic diseases. The company focuses on developing and delivering treatments for conditions where no current therapies exist, utilizing a variety of drug modalities tailored to each disease. Ultragenyx boasts a robust and diverse clinical pipeline, with therapies in development for genetic diseases such as Wilson Disease, osteogenesis imperfecta, and Angelman Syndrome. With a passionate team and a commitment to patient advocacy, Ultragenyx aims to lead the way in pioneering therapies that significantly impact rare disease communities.

📋 Description

• 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.

🏖️ 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