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    Experienced Regulatory Affairs Specialist - Cincinnati, United States - Medpace

    Medpace
    Medpace Cincinnati, United States

    3 weeks ago

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    Description
    Job Summary:

    Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Operations Associate to join our Regulatory Affairs team in Cincinnati. This position will work on a team to accomplish tasks and projects that are instrumental to the companys 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.

    Responsibilities :
    • Coordinate all aspects of document-level publishing (e.g., Clinical Study Protocols, Clinical Study Reports, eCTD modules)
    • Assemble electronic regulatory submission packages for US FDA, Health Canada, and other regulatory authorities;
    • Perform peer reviews to ensure document and submission quality;
    • Assist in the design and implementation of new processes or initiatives within the department;
    • Support with the conduct of procedural and software training;
    • Maintain a working knowledge of applicable standard operating procedures (SOPs), regulations, guidance documents, and policies;
    • Participate in and conduct formal interactions with project teams and clients; and
    • Other projects and responsibilities as assigned.
    Qualifications :
    • Bachelors Degree in life sciences required;
    • Minimum 3 years experience in management of submissions to regulatory authorities;
    • Advanced working knowledge of eCTD Management software (LORENZ docuBridge), Adobe, ISI toolbox, and Microsoft Office; and
    • Supervisory experience preferred.
    Medpace Overview :

    Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

    Why Medpace?:

    People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

    The work weve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

    Cincinnati Perks

    • Cincinnati Campus Overview
    • Hybrid work-from-home options (dependent upon position and level)
    • Competitive PTO packages, starting at 20+ days
    • Competitive compensation and benefits package
    • Flexible work schedule
    • Company-sponsored employee appreciation events
    • Employee health and wellness initiatives
    • Community involvement with local nonprofit organizations
    • Discounts on local sports games, fitness gyms and attractions
    • Modern, ecofriendly campus with an on-site fitness center
    • Structured career paths with opportunities for professional growth
    • Discounted tuition for UC online programs

    Awards

    • Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
    • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

    What to Expect Next

    A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

    EO/AA Employer M/F/Disability/Vets

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