Start-Up Specialist

Clinical Development CenterMexico City Are you passionate about clinical trials and regulatory submissions? Do you want to play a key role in ensuring high-quality execution of study start-up activities? If so, we are looking for a Start-Up Specialist to join our team and make a difference. Read more and apply today! Your new roleAs 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 submi...