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

    Medpace
    0-3 years
    Not Disclosed
    Remote - Europe
    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.

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