Experienced Country Start Up Specialist

				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:

* Provide day-to-day departmental/project support activities, such as collection of vital documents for ethics submissions and preparation of study documents to competent authorities;
* Support Regulatory Submission Managers and Start Up teams in ensuring deadlines are adhered to;
* Conduct quality control of documents;
* Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements;
* Perform other tasks as needed.

Qualifications:

* Life Science Bachelor's degree is required, advanced degree preferred (master's/PhD) and at least 3-4 years of regulatory submissions experience;
* Experience with ANVISA (RA) submissions is required;
* Experience with biosafety commission (CTNBio) submissions is desirable;
* Interest or experience with regulatory surveillance and strategy;
* Excellent organizational and prioritization skills;
* Knowledge of Microsoft Office;
* Great attention to detail and excellent oral and written communication skills; and
* Fluency in spoken and written English.

We kindly ask to submit applications in English.
			

Apply

Share this job:

Share this Job

View company profile

Medpace, Inc.

Connect To Our Company