Investigator Sponsored Studies, Project Coordinator

Investigator Sponsored Studies, Project Coordinator - GBS**Category**:Project Management & Agile**Location**:Ciudad de México, Ciudad de México, MX**Position for Novo Nordisk GBS Mexico**- Join Novo Nordisk for a life-changing career establishing and developing a world-class Global Business Service Centre in Mexico City.- This will impact millions of people living with a chronic disease like diabetes and obesity. It will also impact your professional and personal development through offering you the unique chance to pioneer and build an agile unit offering vital business support to the Americas. Get to know us better by visiting our website.**Position Description**As an Investigator Sponsored Studies, Project Coordinator at Novo Nordisk, you will have the following responsibilities:- Oversee the lifecycle management of clinical and real-world evidence Investigator Sponsored Studies (ISS), ensuring seamless coordination from project initiation to completion.- Manage Research Grants Committee ISS review meetings by sending invites, documenting comments, summarizing outcomes, and uploading relevant documentation in the ISS system (Steeprock), while handling all follow-up communications.- Track and facilitate ISS processes in the ISS website system, monitoring US and global reviews, regulatory documentation, amendments, publication status, and ongoing communication with investigators.- Partner with the ISS Director and stakeholders in Clinical Manufacturing and Clinical Supply to manage study drug requests, distribution plans, approvals, and documentation for ISS projects.- Coordinate internal ISS study result read-out meetings and ensure timely communication of study plans and outcomes to stakeholders.- Implement Program Management Best Practices (PMBPs) across the ISS program, collaborating with internal stakeholders to enhance project management processes and identify areas for continuous improvement.**Required Qualifications**We realise that few people are experts at everything. But if you can nod your head at the following attributes, then you could be the person we are looking for:- A university degree in a healthcare-related field.- 3-4 years of experience in healthcare of pharmaceutical industry, with proven experience in clinical trial management is required.- At least 2 years coordinating projects in the pharmaceutical industry, with strong knowledge of project management best practices and methodologies.- Strong knowledge of ICH/GCP guidelines for running clinical trials. Experience working with FDA regulations is a plus.- Fluent in English.**About the department**You will join the Clinical Data Science and Evidence team, a dynamic and collaborative group dedicated to driving excellence in project management. Our team operates in a fast-paced environment, where we support a variety of projects and strategic initiatives. With a hybrid work model, you will have the flexibility to work both remotely and on-site, ensuring a balanced and productive work life.**Working at Novo Nordisk**Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us Together, we go further. Together, we're life changing.**Contact**Deadline**- We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.- At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.