What are the responsibilities and job description for the Regulatory Writer position at Medpace, Inc.?
Overview
Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach. We leverage local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 3,300 people across 36 countries.
Job Summary
Our organization is rapidly growing and we are currently seeking full-time, office-based Regulatory Scientific Writers to join our Regulatory Affairs team. This position will work within a team structure to accomplish tasks and projects that are instrumental to the company’s success. If you would like an exciting career where you use your scientific and clinical knowledge, then may be the opportunity for you.
Responsibilities
- Write clinical protocol synopses, clinical development plans, scientific advice documents, pediatric study plans, IND modules, and other related regulatory documents;
- Coordinate quality control reviews of those documents and maintaining audit trails of changes; and
- Interact closely with the sponsor, and other Medpace subject matter experts.
Qualifications
- Degree in a life science or engineering field (PhD, PharmD, or Advanced Degreed preferred, but not required);
- Prior experience in the research, pharmaceutical, or medical device industry preferred;
- Strong computer skills, project management skills, and a high attention to detail; and
- Strong communication skills (both written and oral).
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.
Awards
- Medpace Named a Top Cincinnati Workplace for 2015, 2016, 2017 and 2018 by the Cincinnati Enquirer
- Winner of the ACRP-Avoca CRO Quality Award in 2018
- Recognized with six CRO Leadership Awards from Life Science Leader magazine
- Eagle Award winner - which recognizes outstanding leadership, professionalism, integrity, and dedication to advancing the clinical research profession through strong site partnerships
What to Expect Next
We look forward to receiving your application. A member of our recruitment team will review your qualifications and if interested, you will be contacted for an interview.
EO/AA Employer M/F/Disability/Vets
*WARNING: Please beware of phishing scams that offer opportunities with Medpace in exchange for sending money. These scammers pose as legitimate employees from actual companies. Please be advised that a Medpace employee will never ask you for a credit card, send you a check, or ask you for any type of payment as part of consideration for a role with our company. All of our careers require that you first complete an online application and go through some sort of interview process.