Job Summary Our LATAM clinical trial activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Manager to join our Study Start Up team in Sao Paulo. This position plays a key role in the clinical trial management process at Medpace. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.
Responsibilities Efficiently manage and successfully execute all aspects of global start-up;Perform quality checks on submission documents and site essential documents;Prepare and approve informed consent forms;Review pertinent regulations to develop proactive solutions to start-up issues and challenges; andPresent during bid defenses, general capabilities meetings, and audits.Qualifications ***We kindly ask that you submit your CV in English*** At least 4 years of regulatory submissions/start-up management experience (leading regulatory/start-up project teams);Knowledge and experience of Clinical Trial Applications within Latam; Strong oral and written communication skills; Team oriented approach and strong leadership skills; Willing to work in an office-based model; andFluency in English & local languageMedpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across almost 40 countries.
Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Medpace Perks Hybrid work-from-home options (dependent upon position and level)Competitive PTO packagesCompany-sponsored employee appreciation events Employee health and wellness initiativesFlexible work scheduleCompetitive compensation and benefits packageStructured career paths with opportunities for professional growthAwards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibilityWhat to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
EO/AA Employer M/F/Disability/Vets
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