Job Summary

Company: Medpace, Inc.
Location: Cincinnati, OH
Industries: Government and Military
Job Type: Full Time; Employee
Years of Experience: 1+ to 2 Years
Job Reference Code: 78502522

Regulatory Affairs Project Manager

About the Job

Regulatory Affairs Project Manager

Job Locations

United States-OH-Cincinnati

Category

Regulatory Affairs

Job Summary

Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Project Manager to join our Cincinnati team! This person will be a key member of Regulatory Affairs project teams to accomplish tasks that are instrumental to the company's success. With this opportunity, you will be able to leverage previous expertise and continue to develop your career further within the drug development industry.

Responsibilities

Coordinate regulatory submissions and serve as the primary point of contact between Sponsors and US FDA;
Coordinate Investigational New Drug (IND) application activities, track and report project status, and establish comprehensive program timelines;
Schedule and lead internal and external project team meetings;
Prepare agendas, presentation materials, and meeting minutes;
Work closely with Regulatory Strategy Leads, Medical Writers, and Regulatory Document Specialists to execute project plans;
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; and
Support other department initiatives as needed.

Qualifications

Bachelor's Degree in life sciences and minimum 2 years' regulatory experience or PhD in life sciences;
Knowledge of the US FDA drug/biologic approval process; and
IND application 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 Us Today.

The 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.

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.

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Job Summary

Regulatory Affairs Project Manager

About the Job

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