.Study Start Up Associate I (Regulatory Submissions) - Argentina - Hybrid SchemeICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity.The Role:As a member of the Study Start Up Team, you will play an integral role in making sure that physicians at our research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.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.What you need to succeed in the role:Bachelor's Degree preferably in Life SciencesMinimum of 1 years' experience or understanding of clinical study start up requirements and activities.Knowledge of local and/or international regulatory processes, including submissions to regulatory authorities and ethics committees.Ability to read and understand clinical protocols, regulatory documents, and study-specific processes.Strong attention to detail and organizational skills.Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment.Excellent communication skills both in English and Spanish.Benefits of Working in ICON:Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment
