Regulatory Submissions Manager
Our client is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach. We leverage local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, the client employs approximately 2,700 people across 36 countries.
We are currently seeking a full-time, office-based Regulatory Submissions Manager to join our Clinical Operations team in Singapore.
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; and
Present during bid defenses, general capabilities meetings, and audits.
More than 5 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;
Regional experience will be highly advantageous
Strong oral and written communication skills.