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 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;
• Support other department initiatives, as needed.

Qualifications

• Bachelor’s Degree in life sciences required; Master’s Degree preferred.
• ³5 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 4,000 people across almost 40 countries.

Why Medpace?

When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.

Organic Growth:Medpace is continuing to grow in all areas globally and has built an expansive research campus at its headquarters in Cincinnati, OH. In 2020, Medpace opened a new seven story building that is approximately 250,000 SQFT. In total, the headquarter's campus includes five buildings and approximately 600,000 SQFT. The company also has expanding office locations in Dallas, TX and Denver, CO.

Perks (vary by location and position):

• On-site fitness center(s)
• Campus walking paths
• Company-sponsored social and wellness events
• Official Sponsor of FC Cincinnati
• Hybrid work-from-home options and flexible work schedule
• On-site Market Place
• Free and covered parking
• Discounts for local businesses
• On campus restaurants and banks coming soon

Awards:

• Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
• Recognized by Forbes as one of America's Best Mid-size Companies in 2021
• Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
• Ranked in the top 10 on the 2021 LinkedIn Top Companies list in Cincinnati

What to Expect Next:

A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.

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