Global Start-Up Lead

3 days ago

Melbourne, Victoria, Australia beBeeManager Full time $100,000 - $115,000

Regulatory Submissions Manager Role

We are seeking an experienced Regulatory Submissions Manager to manage and execute all aspects of global start-up, perform quality checks on submission documents, prepare and approve informed consent forms, review pertinent regulations, and present during bid defenses and audits.

  • Key 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

  • Requirements:
  • 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.

Medpace offers a full-service clinical contract research organization providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries.

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