# Site and SSU Specialist - Tokyo - Office

**Company**: ICON
**Location**: Tokyo
**Work arrangement**: onsite
**Experience**: mid
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/Japan-Tokyo/Business-Operations-Associate---Site-and-SSU-Specialist_JR145152?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_8532e5fd-246

## Description

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a Site and SSU Specialist - Tokyo - Office at ICON, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of innovative treatments and therapies.

**Responsibilities**

- Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.

- Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.

- Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence.

- Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities.

- Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency.

**Your Profile**

- Bachelor's degree in life sciences or a related field.

- Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.

- Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.

- Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.

- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.

**Rewards & Benefits**

- Competitive base salary and performance-related incentives.

- Health and wellbeing programmes including medical, dental, and vision coverage where applicable.

- Retirement and pension plans.

- Life assurance and disability coverage.

- Employee assistance programmes and wellbeing resources.

- Learning and development opportunities through structured training and career pathways.

## Skills

### Required
- life sciences
- clinical research
- regulatory affairs
- ICH-GCP
- project management
- communication

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Source: [Apply at icon.wd3.myworkdayjobs.com](https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/Japan-Tokyo/Business-Operations-Associate---Site-and-SSU-Specialist_JR145152?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)