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.
Responsibilities:
* 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
Qualifications:
* PhD in a life science related field or PharmD;
* At least 3 years of prior medical writing experience in the clinical research or pharmaceutical industry;
* Strong computer skills, project management skills, and a high attention to detail; and
* Strong communication skills (both written and oral).
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