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Regulatory Submissions Manager

Medpace, Inc.
hybrid
Taipei, Taiwan

About this role

Job title: Regulatory Submissions Manager

We are currently seeking a full-time, office-based Study Start Up Submissions Manager to join our Clinical Operations team in Taipei, Taiwan.

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.

Travel:

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