Job Description

Astek is a global leader in technology consulting. With 10 000 experts worldwide, we guide our clients through digital transformation by developing innovative solutions.

In Canada/US, we excel in IT and engineering. We collaborate with leading companies to tackle major technological challenges, putting innovation, collaboration, and excellence at the heart of our actions.

Join a passionate and committed team ready to bring your ideas to life.

Responsibilities:

• Collaborate with clinical and regulatory teams to streamline documentation and submission processes.
• Support regulatory filings and ensure compliance with global standards.
• Manage integrations across systems like Veeva Vault RIM and Clinical Vault to enable seamless data and document flow.
• Analyze and define business requirements, workflows, and data models; maintain traceability and ensure submission readiness.
• Lead testing efforts (UAT), perform risk assessments, and resolve system integration issues.
• Drive continuous improvement through user feedback, workshops, and process optimization.

Profile:

• Proven experience in regulatory affairs, business analysis, or clinical systems.
• Strong knowledge of submission platforms and healthcare compliance standards.
• Ability to translate business needs into functional system requirements.
• Excellent communication and collaboration skills across multi-disciplinary teams.

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