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    Regulatory Affairs Project Manager

    Medpace
    2+ 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 Project Manager

    Location: Cincinnati, OH (Office-Based)

    Company Overview:

    Medpace is a leading full-service Contract Research Organization (CRO), providing comprehensive Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Headquartered in Cincinnati, Ohio, we have over 5,000 employees across 40+ countries. Our mission is to accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach. We specialize in various therapeutic areas, including oncology, cardiology, metabolic diseases, endocrinology, central nervous system disorders, and anti-viral and anti-infective treatments.

    Role Summary:

    We are experiencing rapid growth and are looking for a full-time, office-based Regulatory Project Manager to join our Cincinnati team. In this role, you will be a vital member of our Regulatory Affairs project teams, managing key tasks essential to the success of our projects. This position offers an opportunity to leverage your expertise and further develop your career within the drug development industry.

    Responsibilities:

    • Regulatory Submissions: Coordinate regulatory submissions and act as the primary contact between Sponsors and the US FDA.
    • IND Applications: Manage Investigational New Drug (IND) application activities, track and report project status, and establish comprehensive timelines.
    • Meetings Coordination: Schedule and lead internal and external project team meetings, preparing agendas, presentation materials, and meeting minutes.
    • Collaboration: Work closely with Regulatory Strategy Leads, Medical Writers, and Regulatory Document Specialists to execute project plans.
    • Communication: Maintain clear and effective communication with Sponsors, anticipate potential issues, and work with the team to develop solutions.
    • Team Integration: Foster close collaboration with Medpace functional area colleagues and represent Regulatory Affairs in clinical operations internal meetings.
    • Support: Contribute to other departmental initiatives as needed.

    Qualifications:

    • Education: Bachelor’s Degree in life sciences with a minimum of 2 years of regulatory experience, or a PhD in life sciences.
    • Experience: Knowledge of the US FDA drug/biologic approval process and experience with IND applications.

    Why Medpace?

    Join us at Medpace where People, Purpose, and Passion drive our mission to make a difference in the world of clinical research. We are dedicated to improving the lives of patients through innovative and effective medical therapeutics.

    Cincinnati Perks:

    • Work Flexibility: Hybrid work-from-home options based 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 employee appreciation events, and wellness initiatives.
    • Community Engagement: Opportunities for involvement with local nonprofit organizations and discounts on local sports events, fitness gyms, and attractions.
    • Campus Benefits: Enjoy a 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 and experienced Regulatory Project Manager with a passion for clinical research and regulatory affairs, we invite you to apply and become part of our dynamic team at Medpace.

    Make a Difference Tomorrow. Join Us Today.

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