Regulatory Submissions Manager

Job Information:

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.

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; and

  • Present during bid defenses, general capabilities meetings, and audits.

Qualifications:

  • 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.

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