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

    Medpace
    3-5 years
    Preferred by Comapny
    Georgia
    10 Nov. 25, 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 Opportunity: Regulatory Submissions Coordinator & Contract Specialist (Dual Role)

    Location: Georgia (Home-based)
    Job Requisition ID: 10098
    Department: Site Activation & Maintenance

    About Medpace

    Medpace is a full-service clinical contract research organization (CRO), providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. With over 5,000 employees across 40+ countries, our mission is to accelerate the development of safe and effective medical therapeutics. Headquartered in Cincinnati, Ohio, we positively impact global healthcare, improving the lives of people facing serious diseases.

    Role Overview

    Medpace is seeking a Regulatory Submissions Coordinator & Contract Specialist (Dual Role) based in Georgia. This is a unique opportunity to work across both Regulatory Submissions and Contract Negotiations, supporting a range of clinical research projects. In this home-based role, you will gain hands-on experience and mentorship from experienced professionals, helping you develop a career in clinical research.

    Key Responsibilities

    • Regulatory Submissions:

      • Prepare, review, and file clinical trial applications to regulatory authorities and Ethics committees in Georgia.
      • Submit responses to queries and amendments to clinical trial applications.
      • Ensure compliance with applicable regulations and guidance documents.
      • Advise on changing regulations and compliance requirements.
      • Maintain Clinical Trial Management System and ensure timely document filing.
      • Collect essential documents and prepare essential packages for drug release.

    • Contract Management:

      • Draft, review, negotiate, and finalize agreements, termination letters, and other legal documents related to clinical studies.
      • Identify and assess legal, financial, and operational risks and escalate issues when necessary.
      • Provide recommendations and alternative solutions during negotiations using established escalation channels.
      • Coordinate with internal departments to ensure alignment of site startup activities with contractual timelines.

    Qualifications

    • Education: A minimum of a Bachelor's degree (preferably in Life Sciences or Law).
    • Experience:
      • Experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies.
      • Experience at a CRO, pharmaceutical company, or investigative site is preferred.
      • Knowledge of local regulatory guidelines and legislation in Georgia.
    • Skills:
      • Organizational and prioritization skills.
      • Proactive, independent work style.
      • Proficiency with Microsoft Office.
      • Fluency in Georgian and English.
      • Attention to detail and excellent oral and written communication skills.

    Why Medpace?

    Perks & Benefits

    • Flexible work environment and competitive compensation.
    • Competitive PTO and benefits packages.
    • Structured career paths with opportunities for professional growth.
    • Employee health and wellness initiatives and company-sponsored events.

    Recognition & Awards

    • Forbes: Recognized as one of America’s Most Successful Midsize Companies (2021, 2022, 2023, 2024).
    • CRO Leadership Awards from Life Science Leader Magazine for expertise, quality, reliability, and capabilities.

    How to Apply

    To apply for this exciting opportunity, please visit Medpace’s career page and submit your application in English for Job Requisition ID 10098.

    Join Medpace and help us make a difference in global healthcare!

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