Medical Writer

Job Description

Overview

Medpace is a scientifically-driven, global, full-service clinical contract research organisation (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 3,000 people across 40 countries.

Job Summary

Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based senior level Medical Writer to join our Medical Writing/Regulatory Affairs team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities

• Write quality clinical study reports, protocols, protocol amendments and potentially other regulatory documents such as clinical development plans, FDA briefing documents, and IND, NDA, and MAA modules;
• Project manage writing assignments with internal teams including medics, statisticians, clinical operations, etc.;
• Coordinate and periodically conduct quality control reviews of documents and maintaining audit trails of changes;
• Provide input on data analysis planning and interpretation;
• Work on new and complex projects with no oversight; and
• Mentor and train less experienced Medical Writers.

Qualifications

• PhD preferred in biology or related field, Masters Degree in a life science considered;
• Significant experience in Medical writing including being the primary author on Ph 1-3 clinical study protocols and clinical study reports under ICH E3 guidance;
• Demonstrated experience in project leadership skills;
• Experienced in Mentoring and training others;
• Prior experience in the clinical research, pharmaceutical;
• Excellent Microsoft office 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.