Bachelor's degree in a Life Sciences field is required., 3-4 years of regulatory submissions experience is necessary., Excellent organizational, prioritization, and communication skills are essential., Fluency in spoken and written English is required..
Key responsabilities:
Provide support for ethics submissions and preparation of study documents.
Assist Regulatory Submission Managers in meeting deadlines.
Conduct quality control of documents and maintain reports.
Offer guidance to team members to ensure compliance with regulations.
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Medpace is a scientifically-driven, global, full-service clinical contract research organization (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 that leverages local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 5,800 people across 43 countries.
Join Medpace in Chile! As a Regulatory Submissions Coordinator you will have the opportunity to work within Regulatory Submissions, supporting our many projects and gaining 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;
Maintain spreadsheets and compile reports; and
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);
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.
We kindly ask to submit applications in 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?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Medpace Perks
Flexible work environment
Competitive compensation and benefits package
Competitive PTO packages
Structured career paths with opportunities for professional growth
Company-sponsored employee appreciation events
Employee health and wellness initiatives
Awards
Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What To Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
EO/AA Employer M/F/Disability/Vets
Required profile
Experience
Spoken language(s):
English
Check out the description to know which languages are mandatory.