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Regulatory Submissions-Start Up & Contract Specialist (Dual Role)

0-2 years
Not Disclosed
10 Jan. 13, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Regulatory Submissions Coordinator & Contract Specialist (Dual Role)

Location: Home-based, Georgia
Department: Clinical Operations
Company: Medpace


Job Summary

We are seeking a Regulatory Submissions Coordinator & Contract Specialist to join our growing Clinical Operations team in Georgia. This dual-role position involves preparing and managing regulatory submissions while handling contract negotiations for clinical studies. You will play a vital role in supporting our projects and gaining hands-on experience to develop your career in clinical research.

Note: This position requires you to be based in Georgia. Applications in English are preferred.


Responsibilities

Regulatory Submissions:

  • Prepare, review, and submit clinical trial applications to regulatory authorities and Ethics Committees in Georgia.
  • Handle amendments and respond to queries regarding clinical trial applications.
  • Ensure all submissions comply with local regulations and guidelines.
  • Maintain the Clinical Trial Management System (CTMS) and ensure timely document filing.
  • Advise internal teams on updates to regulatory requirements.

Contract Management:

  • Draft, review, negotiate, and finalize agreements, termination letters, and other legal documents for clinical studies.
  • Identify and assess legal, financial, and operational risks, escalating as necessary.
  • Provide recommendations and resolve issues during negotiations using established escalation channels.
  • Coordinate site startup activities with internal departments to align timelines with contractual processes.

Qualifications

  • Bachelor’s degree in Life Sciences or Law is required.
  • Proven experience preparing and submitting regulatory documentation to Ethics Committees and regulatory agencies.
  • Relevant work experience in a CRO, pharmaceutical company, or investigative site.
  • Familiarity with local regulatory guidelines and legislation.
  • Excellent organizational and prioritization skills with a proactive mindset.
  • Strong command of Microsoft Office tools.
  • Fluency in Georgian and English (oral and written).
  • Great attention to detail and excellent communication skills.

About Medpace

Medpace is a global, full-service clinical contract research organization (CRO) specializing in Phase I-IV clinical development services. With over 30 years of experience, we accelerate the development of safe and effective therapeutics through scientific expertise and disciplined processes. Headquartered in Cincinnati, Ohio, we operate in 40+ countries and employ more than 5,000 professionals.


Why Medpace?

People. Purpose. Passion.

  • Work on projects that positively impact global healthcare.
  • Be part of a collaborative and supportive team.
  • Develop your career through structured career paths and mentorship.

Medpace Perks

  • Flexible Work Environment: Enjoy home-based flexibility.
  • Competitive Benefits: Comprehensive compensation and PTO packages.
  • Career Development: Opportunities for professional growth and advancement.
  • Employee Engagement: Participate in company-sponsored appreciation events and health initiatives.

Awards and Recognition

  • Recognized by Forbes as one of America’s Most Successful Midsize Companies (2021–2024).
  • Awarded CRO Leadership Awards for quality, expertise, and reliability.

What to Expect Next

A Medpace team member will review your qualifications. If selected, you will be contacted with details on the next steps.

Medpace is an Equal Opportunity Employer, welcoming diversity and inclusion across all levels.