Our corporate activities are growing rapidly, and we are currently seeking a full-time, Regulatory Project 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.
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 in scope 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.
Bachelor’s Degree in life sciences required; Master’s Degree preferred
3 years of project management experience in a clinical research or pharmaceutical setting preferred
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 approximately 3,500 people across almost 40 countries.