Experienced Country Start Up Specialist
2 semanas atrás
Join to apply for the Experienced Country Start Up Specialist role at Medpace . Our team in Brasil is growing As a Regulatory Submissions Coordinator you will have the opportunity to work within Regulatory Submissions, supporting our many projects and gaining vital experience in study start up. 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.
- Life Science Bachelors 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.
Medpace OverviewMedpace 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
- 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
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
Seniority level- Not Applicable
- Full-time
- Other
- Industries
- Pharmaceutical Manufacturing
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