Director of Compliance managing Regulatory Compliance team at Intact Financial Corporation. Leading regulatory compliance, risk management, and team development with high - performing professionals.
About the role
- Study Start Up Associate II at ICON facilitating regulatory submissions and study progress for clinical trials. Collaborating with diverse teams to maintain regulatory compliance and document approvals.
Responsibilities
- Lead regulatory submissions that enable trials to start on time – Prepare and submit clinical trial applications, ethics committee submissions, and communications with regulatory authorities, ensuring every study begins with the highest standards of compliance and integrity.
- Coordinate across teams and stakeholders to unlock study progress – Liaise with internal colleagues and external partners to secure approvals and authorizations, keeping studies on track and supporting patient access to innovative treatments.
- Ensure transparency and accuracy in all regulatory records – Maintain comprehensive documentation of submissions, approvals, and correspondence so that study decisions are informed, traceable, and compliant with global and local regulations.
- Empower study teams with regulatory expertise – Provide guidance and support on study start-up requirements, helping colleagues navigate complex regulatory processes efficiently and effectively.
- Drive process improvements that accelerate research – Identify opportunities to optimize start-up workflows, enhancing efficiency and contributing to ICON’s culture of quality and innovation.
Requirements
- Bachelor’s degree in Life Sciences or a related field.
- Minimum 2 years of experience in clinical research or regulatory affairs, with hands-on experience in study start-up submissions.
- Strong knowledge of ICH-GCP and local regulatory requirements.
- Fluent in English and one additional European language: German, Czech, or Dutch.
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.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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