Country Start Up Specialist

Job Summary:As a Regulatory Submissions Coordinator you will have the opportunity to work within Regulatory Submissions, supporting our many projects and gaining some vital experience.
You will be a productive member of the team, and will be mentored and supported as you develop your skills.
Working directly with Regulatory Submissions Coordinators, you will gain valuable hands on experience to enable you to develop a career in clinical research.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:- Bachelor's degree is required (preferably in a Life Sciences field) and at least 3 - 4 years of regulatory submissions experience;- 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._Medpace 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.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.Organic Growth:*Medpace is continuing to grow in all areas globally and has built an expansive research campus at its headquarters in Cincinnati, OH.
In 2020, Medpace opened a new seven story building that is approximately 250,000 SQFT.
In total, the headquarter's campus includes five buildings and approximately 600,000 SQFT.
The company also has expanding office locations in Dallas, TX and Denver, CO.Perks (vary by location and position):- On-site fitness center(s)- Campus walking paths- Company-sponsored social and wellness events- Official Sponsor of FC Cincinnati- Hybrid work-from-home options and flexible work schedule- On-site Market Place- Free and covered parking- Discounts for local businesses- On campus restaurants and banks coming soonAwards:- Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer- Recognized by Forbes as one of America's Best Mid-size Companies in 2021- Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility- Ranked in the top 10 on the 2021 LinkedIn Top Companies list in CincinnatiWhat to Expect Next: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_
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