Medpace - Sr Study Start up - Regulatory Submissions Coordinator

Medpace is a global, full-service Clinical Research Organization (CRO) specializing in a multitude of therapeutic areas. Our headquarters are located in Cincinnati, Ohio and we are active in over 45 countries across the globe. We continue to steadily grow and are looking to add to our team!

Our clinical activities are growing rapidly, and we are currently seeking a full-time, home-based Regulatory Submissions Coordinator in Moscow to join our Clinical Operations team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Ours is a culture 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 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 talented individuals join the Medpace team.

Responsibilities

  • Prepare, review, and file clinical trial applications to regulatory agencies and ethics committees
  • Ensure submissions comply with applicable regulations and guidance documents;
  • MoH liaison;
  • Interpretation of Russian Regulations and Law;
  • Participation in clinical research community meetings in Moscow; and
  • Track submissions and ensure timely filing of documents.

Qualifications

  • Bachelor's degree;
  • 4 years regulatory submissions experience;
  • Direct MoH support experience;
  • Demonstrate ability to independently manage overall project timelines for regulatory submissions;
  • Excellent organization and communication skills;
  • Knowledge of Microsoft® Office;
  • Hands-on experience preparing, reviewing, and submitting regulatory documentation;
  • Fluency in English and Russian language.

WHY MEDPACE?

At Medpace, you will find work that is both challenging and rewarding. At Medpace, you will be given the tools and training to succeed. At Medpace, you will be rewarded for strong performance and provided opportunities to grow professionally.

WHAT TO EXPECT NEXT

We look forward to receiving your application. A member of our recruitment team will review your qualifications. If interested, you will be contacted for an interview.

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*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.