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March

Regulatory Submissions Coordinator

Medpace - South Melbourne, VIC

Biotech, R&D, Science
Source: uWorkin

JOB DESCRIPTION

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 approximately 3,500 people across almost 40 countries.

Job Summary

We are currently seeking a full-time, office-based Regulatory Submissions Coordinator to join our Clinical Operations team in the Australia, Melbourne office. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you.

Our culture is of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our business partners. At Medpace, our employees embody our values and our approach to serving our clients. They work hard, understand our high expectations, and rise to the challenge. In return they are rewarded with interesting projects, career advancement, and recognition and exposure to our international footprint. These are just a few reasons why talented individuals join the Medpace team.

Responsibilities

  • Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials;
  • Prepare, review, and submit to Regulatory Agencies (TGA / Medsafe);
  • Communicate with global study teams and personnel on study progress;
  • Ability to effectively identify risks to site activations and mitigate as necessary;
  • Provide expertise and guidance to global study teams in ethics and regulatory submissions;
  • Review and finalize essential documents required for site activation;
  • Act as a main contact for Ethical and Regulatory submission-related activities;
  • Direct contact with investigative sites during the study start up and activation process;
  • Ensure submissions comply with applicable regulations and guidance documents;
  • Advise sponsors on changing regulations and compliance requirements; and
  • Track submissions and ensure timely filing of documents.

Qualifications
  • Bachelor's degree in the science field or equivalent combination of education and experience;
  • At least two year of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site;
  • Experience in preparing and submitting TGA regulatory applications;
  • Excellent organization and communication skills;
  • Knowledge of Microsoft® Office;
  • Knowledge of ICH - GCP guidelines and regulatory guidelines in Australia and New Zealand;
  • Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries; and
  • Proactive approach to role with ability and willingness to learn and be challenged.

Why Medpace?

When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.

Awards
  • Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
  • Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
  • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What To Expect Next

A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.

EO/AA Employer M/F/Disability/Vets

  • WARNING: Please beware of phishing scams that offer opportunities with Medpace in exchange for sending money. These scammers pose as legitimate employees from actual companies. Please be advised that a Medpace employee will never ask you for a credit card, send you a check, or ask you for any type of payment as part of consideration for a role with our company. All of our careers require that you first complete an online application and go through some sort of interview process.
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