Job Closed

This listing is no longer active.

Ultragenyx logo
Ultragenyx

Rare mission. Fearless team. Incredible possibilities.

Early Access Operations Specialist

OperationsOperationsFull TimeRemoteMid LevelTeam 501-1,000Since 2010H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

4 days ago

Salary

$82.2K - $101.5K / year

Seniority

Mid Level

2 yrs expEnglishGoogle Cloud Platform

Job Description

Early Access Operations Specialist

Ultragenyx

• 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.

Job 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

Related Categories

Related Job Pages

More Operations Jobs

Werecruiter logo

Analista de SupportOps

Werecruiter

Recrutamento para área de tecnologia com Fit Cultural e Aderência Técnica.

Operations4 days ago
Full TimeRemoteTeam 1-10Since 2020H1B No Sponsor

• Consolidar e garantir a qualidade dos dados da operação de suporte. • Definir, acompanhar e evoluir indicadores operacionais (SLA, TMR, TMA, backlog, aging, throughput, entre outros). • Criar dashboards executivos e operacionais para acompanhamento da performance. • Desenvolver análises críticas da operação, identificando desvios, gargalos e oportunidades de melhoria. • Apoiar a liderança na tomada de decisões por meio de dados e indicadores. • Monitorar o cumprimento dos SLAs e a performance das filas de atendimento (N1, N2 e N3). • Elaborar previsões de demanda (forecast) e análises de capacidade operacional. • Padronizar métricas, conceitos e fontes de informação. • Automatizar relatórios e processos de extração de dados. • Atuar na administração e evolução do Zendesk, garantindo qualidade na configuração da ferramenta e confiabilidade das informações. • Promover uma cultura data-driven na operação de suporte.

Brazil
Full TimeRemoteTeam 51-200H1B Sponsor

• Provide first- and second-level remote IT support (helpdesk, chat, or video) to resolve connectivity, device, and application issues and keep downtime low • Manage company devices through an MDM solution including encryption, remote wipe, and security policy enforcement • Run IT onboarding and offboarding: account setup, device provisioning, role-based access and MFA, and full access revocation on the day of separation, in coordination with HR • Monitor and respond to endpoint security alerts and support basic incident response • Maintain IT asset inventory

Philippines
Tremendous logo

Operations Analyst

Tremendous

Tremendous lets businesses send one-off payments to people around the world.

Operations4 days ago
Full TimeRemoteTeam 51-200Since 2014H1B Sponsor

• Review account activity and make informed decisions using AI-assisted analysis. • Identify suspicious activity and fraud patterns. • Suggest process improvements that could make things more efficient or reduce risk. • Balance compliance with user experience by using AI to process large datasets.

North America
$95K - $105K / year

Role Description The Development and Operations Associate (Part-Time) will play a critical role in supporting the internal operations of the Development team by facilitating high-impact fundraising campaigns and partnerships to ensure the long-term sustainability of StartOut. Supervised by the Director of Development, this role will focus on developing and implementing fundraising strategies, collaborating with cross-functional teams to manage large-scale projects, and supporting the frontline fundraisers to advance StartOut’s mission. The position also provides administrative support to the Board of Directors and senior leadership, and manages the organization’s inbox. The ideal candidate will be highly organized and detail-oriented, possess excellent communication and collaboration skills, and have a strong interest in development/operations work. Qualifications - Organized: Proven background in organization and detail orientation. - Proficient in Salesforce: Knowledge of navigating Salesforce or a similar CRM. - Collaborator: Recognized success in creating relationships with cross-functional teams. - Communicator: Proven skill in distilling complex information into compelling narratives. - Operations Management: Experience in managing complex projects and balancing competing priorities. - Service Delivery and Adaptability: Commitment to outstanding service and flexibility in change. - Mission and Culture Alignment: Awareness and support for StartOut’s mission and vision. Requirements - Proficiency with Salesforce (or a similar database system) is preferred. - One-to-two years of successful experience in fundraising or high-level sales. - Corporate fundraising experience is preferred but not required. - Demonstrated ability to work collaboratively in a team-based environment. - Excellent communication, presentation, business development, organization, and computer skills required. - Experience organizing Google Drive. - Knowledge of using AI to augment work is a huge plus. Benefits - $25/hr; 20 hrs per week - Unlimited time off - Professional development stipends - Work from home equipment

United States
$25 / hour