Key skills
Communication
About this role
Role Overview
- Assisting in the preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions.
- Coordinating with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
- Maintaining accurate and up-to-date records of regulatory submissions and approvals.
- Supporting study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures.
- Participating in study start-up meetings and providing input on regulatory requirements and timelines.
Requirements
- Bachelor's degree in life sciences or a related field.
- Previous experience in clinical research or regulatory affairs preferred, but not required.
- Strong attention to detail and organizational skills.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment.
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.