Start-Up Specialist

Clinical Development Center, Mexico City

Your new role

As a Start-Up Specialist at Novo Nordisk, you will lead, coordinate, and manage the execution of start-up activities for assigned trials. Your responsibilities will include:

• Prepare, review, and submit Health Authority (HA) and Ethics Committee (EC) dossiers in compliance with ICH GCP regulations and local requirements.
• Develop regulatory strategies and start-up plans in collaboration with trial teams and SSU Managers.
• Perform quality control and ensure timely site activation by managing essential documents and training plans.
• Engage with cross-functional teams, clinical sites, and external stakeholders to ensure alignment and timely delivery of start-up and submission activities.
• Provide local regulatory insights and support continuous improvement initiatives related to study start-up and compliance.
• Ensure adherence to ICH GCP, regulatory requ...