If you are looking for an opportunity to launch a career in regulatory/medical writing or regulatory affairs, this could be the opportunity for you!
The Medpace Regulatory Affairs team is growing rapidly. We are looking for a full-time Regulatory Writer to join our team in the Cincinnati office. In this position, you will make important contributions to research in the fast-paced medical world.
At Medpace, our mission is to accelerate the global development of safe and effective medical therapeutics through offering world-class clinical research operations. As a Regulatory Writer, you will write IND modules, NDA modules, briefing documents to support interactions with the FDA and EMA and other related regulatory documents. You will be a key member within the Regulatory Affairs team to support biotech clients who are developing a wide range of products: small molecule drugs, recombinant protein biologics, monoclonal antibodies, medical devices, and cell and gene therapies in indications spanning oncology, cardiovascular, neurology, metabolic disorders, rare diseases, and other areas.
- Write IND modules, NDA modules and other related regulatory documents
- Write clinical study reports, protocols, and protocol amendments
- Coordinate quality control reviews of those documents and maintain audit trails of changes
- Interact closely with the sponsor, and other Medpace subject matter experts
- PhD degree in a life science;
- Strong computer skills, project management skills, and a high attention to detail; and
- Strong communication skills (both written and oral).
This is an office-based position in Cincinnati, Ohio. Please visit our website for more details: www.medpace.com/careers. Look for the term: “Medical Writer” to locate the job posting. If you are interested in this position or have any questions, please contact Suzanna Hete at S.Hete@medpace.com