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    Experienced Regulatory Affairs Specialist

    Medpace
    3+ years
    Preffered by Company
    Remote
    10 Aug. 26, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/Any 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 Operations Associate

    Location: Cincinnati, OH (Office-Based)

    Company Overview:

    Medpace is a premier full-service Contract Research Organization (CRO) specializing in Phase I-IV clinical development services for the biotechnology, pharmaceutical, and medical device industries. With our headquarters in Cincinnati, Ohio, and over 5,000 employees across 40+ countries, our mission is to expedite the global development of safe and effective medical therapeutics. We leverage extensive regulatory and therapeutic expertise in areas such as oncology, cardiology, metabolic diseases, endocrinology, central nervous system disorders, and anti-viral and anti-infective treatments.

    Role Summary:

    We are seeking a full-time, office-based Regulatory Operations Associate to join our Regulatory Affairs team in Cincinnati. This role is crucial for managing the documentation and submission processes that are key to our company's success. If you are looking for a dynamic career where you can utilize your expertise and grow professionally, this is your opportunity.

    Responsibilities:

    • Document Management: Coordinate all aspects of document-level publishing, including Clinical Study Protocols, Clinical Study Reports, and eCTD modules.
    • Submission Preparation: Assemble electronic regulatory submission packages for the US FDA, Health Canada, and other regulatory authorities.
    • Quality Assurance: Perform peer reviews to ensure the quality of documents and submissions.
    • Process Improvement: Assist in designing and implementing new processes or initiatives within the department.
    • Training Support: Support the conduct of procedural and software training.
    • Regulatory Knowledge: Maintain up-to-date knowledge of applicable standard operating procedures (SOPs), regulations, guidance documents, and policies.
    • Project Interaction: Participate in and conduct formal interactions with project teams and clients.
    • Additional Tasks: Undertake other projects and responsibilities as assigned.

    Qualifications:

    • Education: Bachelor’s Degree in life sciences.
    • Experience: Minimum of 3 years’ experience managing submissions to regulatory authorities.
    • Technical Skills: Advanced working knowledge of eCTD management software (e.g., LORENZ docuBridge), Adobe, ISI Toolbox, and Microsoft Office.
    • Supervisory Experience: Preferred but not required.

    Why Medpace?

    At Medpace, we are driven by People, Purpose, and Passion. Join us and contribute to making a meaningful impact on patients’ lives through our innovative clinical research.

    Cincinnati Perks:

    • Work Flexibility: Hybrid work-from-home options available, depending on position and level.
    • Generous PTO: Competitive paid time off packages starting at 20+ days.
    • Compensation: Attractive salary and benefits package.
    • Work-Life Balance: Flexible work schedules, company-sponsored appreciation events, and wellness initiatives.
    • Community Engagement: Opportunities for involvement with local nonprofit organizations and discounts on local sports games, fitness gyms, and attractions.
    • Campus Amenities: Modern, eco-friendly campus with an on-site fitness center.
    • Career Development: Structured career paths, professional growth opportunities, and discounted tuition for UC online programs.

    Awards and Recognition:

    • Top Workplace: Named a Top Workplace in 2024 by The Cincinnati Enquirer.
    • Forbes Recognition: Recognized by Forbes as one of America's Most Successful Midsize Companies (2021-2024).
    • CRO Leadership Awards: Continually honored with CRO Leadership Awards from Life Science Leader magazine for expertise, quality, capabilities, reliability, and compatibility.

    Apply Today:

    If you are a dedicated professional with experience in regulatory operations and a passion for clinical research, we invite you to apply and join our dynamic team at Medpace.

    Make a Difference Tomorrow. Join Us Today.

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