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Regulatory Affairs Manager

Company: Medpace, Inc.
Location: Hamilton
Posted on: November 21, 2022

Job Description:

Job Summary:Our corporate activities are growing rapidly, and we are currently seeking a full-time, Regulatory Affairs Manager. This person will be a key member of Regulatory Affairs project teams to accomplish tasks and projects that are instrumental to the company's success. With this opportunity, you will be able to leverage previous expertise and continue to develop and grow your career even further within the drug development industry.Responsibilities :This position is for experienced candidates; Support portfolio management for Sponsors; Partner with cross-functional teams to execute Sponsor programs; Engage in the preparation and maintenance of regulatory submissions and files; Assign projects or activities, provide day-to-day instructions, and suggested training activities to direct reports, as needed; Coordinate project start-up activities, track and report project status, and maintain project documentation such as communication plans, submission timelines, and task orders/scopes of work; Serve as the primary point of contact for Sponsors and regulatory authorities; Maintain comprehensive project timelines including projects with multiple regulatory submissions; Escalate changes inscope following communication with the project team; Schedule and lead internal and external project team meetings; Prepare presentation materials for project team meetings such as internal and sponsor-facing kick-off meetings; Develop meeting agendas and minutes for project team meetings; Work closely with other Regulatory Affairs project team members such as Regulatory Strategy Leads, Regulatory Science Managers, Medical Writers, and Regulatory Document Specialists to execute project plans; Report project metrics and perform project close-out activities; Maintain clear and effective Sponsor communication, identify and anticipate possible issues and/or challenges, and work with the project team to develop solutions; Maintain close collaboration, interaction, and effective working relationships with Medpace functional area colleagues; Attend clinical operations internal meetings as the Regulatory Affairs representative; Support other department initiatives, as needed.Qualifications :Bachelor's Degree in life sciences required; Master's Degree preferred. -5 years of biopharma or CRO regulatory affairs experience.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 TodayThe work we've 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.Medpace Celebrates 30 YearsAs we celebrate 3 decades of industry expertise and organic growth, we recognize the global team responsible for driving clinical development at Medpace. Click here to learn more about Medpace Celebrating 30 Years.Cincinnati PerksCincinnati Campus OverviewHybrid work-from-home options (dependent upon position and level)Competitive PTO packages, starting at 20+ daysFlexible work hoursDiscounted tuition for UC online programsCompany-sponsored employee appreciation eventsEmployee health and wellness initiativesCommunity involvement with local nonprofit organizationsCompetitive compensation and benefits packageStructured career paths with opportunities for professional growthPartnership and discount with onsite childcareDiscounted tuition for UC online programsDiscounts on local sports games, local fitness gyms and attractionsOfficial Sponsor of FC CincinnatiModern, ecofriendly campus with an on-site fitness center, bar, and restaurantsAwards:Recognized by Forbes as one of Americas Best Mid-size Companies in 2021 and 2022Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibilityWhat to Expect Next:A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Keywords: Medpace, Inc., Hamilton , Regulatory Affairs Manager, Executive , Hamilton, Ohio

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