Join Medpace as a full‑time, office‑based Regulatory Submissions Manager in Mexico City. This role plays a key part in the study start‑up process, building on your experience in clinical trials and regulatory submissions. You will use your expertise to develop and grow your career while supporting our LATAM clinical trial activities.
Responsibilities
- Efficiently manage and successfully execute all aspects of global start‑up.
- Perform quality checks on submission documents and site essential documents.
- Prepare and approve informed consent forms.
- Review pertinent regulations to develop proactive solutions to start‑up issues and challenges.
- Present during bid defenses, general capabilities meetings, and audits.
Qualifications
- Submit your CV in English.
- Minimum education: bachelor’s degree in a life science major.
- At least 4 years of regulatory submissions/start‑up management experience, leading regulatory/start‑up project teams.
- Knowledge and experience of Clinical Trial Applications within Latin America.
- Strong oral and written communication skills.
- Team‑oriented approach and strong leadership skills.
- Willing to work in an office‑based model.
- Fluency in English and the local language.
Company Overview
Medpace is a full‑service clinical contract research organization (CRO) providing Phase I‑IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the integral development of safe and effective medical therapeutics through a scientific and disciplined approach. With expertise across oncology, cardiology, metabolic disease, endocrinology, central nervous system, and anti‑viral and anti‑infective areas, Medpace is headquartered in Cincinnati, Ohio and employs more than 5,000 people in nearly 40 countries.
Why Medpace?
People, purpose, and passion drive our impact. Over the past 30+ years, we have positively impacted the lives of patients and familie
📌 Study Start Up Manager (Ciudad de México)
🏢 Medpace
📍 Ciudad de México
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