Entry Level Regulatory Project Manager

Company

medpace

Description

Job Summary
Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Entry Level 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.
Responsibilities
* This is a training position for entry-level candidates;
* Coordinate submissions between Sponsors and regulatory authorities;
* Cross-train with Regulatory Operations to learn technical components of regulatory submissions;
* 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, as needed;
* 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 sponsorfacing 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
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 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.
Medpace Celebrates 30 Years
As 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 Perks
* Cincinnati Campus Overview
* Hybrid work-from-home options (dependent upon position and level)
* Competitive PTO packages, starting at 20+ days
* Flexible work hours
* Discounted tuition for UC online programs
* Company-sponsored employee appreciation events
* Employee health and wellness initiatives
* Community involvement with local nonprofit organizations
* Competitive compensation and benefits package
* Structured career paths with opportunities for professional growth
* Partnership and discount with onsite childcare
* Discounted tuition for UC online programs
* Discounts on local sports games, local fitness gyms and attractions
* Official Sponsor of FC Cincinnati
* Modern, ecofriendly campus with an on-site fitness center, bar, and restaurants
Awards:
* Recognized by Forbes as one of America's Best Mid-size Companies in 2021 and 2022
* 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.