Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

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

Medpace
Medpace
0-3 years
Not Disclosed
10 Nov. 22, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job Title: Regulatory Submissions Coordinator & Contract Specialist (Dual Role)
Company: Medpace
Location: Home-Based, Georgia


Job Summary
Medpace is seeking a Regulatory Submissions Coordinator & Contract Specialist to join our Clinical Operations team in Georgia. This dual-role position offers a unique opportunity to engage in both regulatory submissions and contract negotiations, supporting various clinical research projects. With mentoring and development opportunities, you’ll gain valuable hands-on experience and contribute to our mission of advancing clinical research. This is a home-based, full-time, permanent role, requiring residence in Georgia.


Key Responsibilities

  • Prepare, review, and file initial clinical trial applications to regulatory authorities and ethics committees.
  • Respond to queries and amend clinical trial applications as needed.
  • Ensure submissions comply with local regulations and guidance documents.
  • Advise teams on regulatory updates and compliance requirements.
  • Maintain and update the Clinical Trial Management System (CTMS).
  • Prepare essential document packages for drug release.
  • Draft, review, negotiate, and finalize clinical study agreements and related legal documents.
  • Identify and escalate legal, financial, or operational risks to appropriate stakeholders.
  • Coordinate with internal departments to align site startup activities with contractual timelines.

Qualifications

  • Education: Bachelor’s degree in Life Sciences or Law preferred.
  • Experience: Previous experience with regulatory submissions and documentation in a CRO, pharmaceutical company, or investigative site.
  • Familiarity with local regulatory guidelines and legislation.
  • Strong organizational, prioritization, and independent working skills.
  • Proficiency in Microsoft Office and CTMS tools.
  • Fluency in Georgian and English (oral and written).
  • Attention to detail with excellent communication skills.

Note: Applications must be submitted in English.


Why Medpace?

Purpose-Driven Work
Medpace accelerates the development of medical therapeutics, making a tangible impact on patient health worldwide.

Growth-Oriented Environment

  • Flexible, home-based work structure.
  • Competitive salary and PTO packages.
  • Opportunities for professional growth and advancement.

Community and Culture

  • Employee wellness programs and appreciation events.
  • Collaborative teams with access to cutting-edge clinical research projects.

About Medpace
Medpace is a full-service clinical contract research organization (CRO) specializing in Phase I-IV clinical development. Headquartered in Cincinnati, Ohio, with operations in 40+ countries, Medpace brings scientific expertise across major therapeutic areas such as oncology, cardiology, endocrinology, CNS disorders, and infectious diseases.


Awards & Recognition

  • Named one of America’s Most Successful Midsize Companies by Forbes (2021–2024).
  • Honored with CRO Leadership Awards by Life Science Leader Magazine for reliability, expertise, and quality.