Analista de protocolo Trainee II
Core
Designing bioequivalence/bioavailability study protocols, managing clinical unit pharmacy operations, and supporting regulatory submissions for life sciences research.
Role type
Junior clinical research protocol analyst (bioequivalence)
Builds
Bioequivalence study protocols and regulatory documentation
Domain
Life sciences / Clinical research / Bioequivalence
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Protocol design, regulatory document preparation, scientific article review, clinical trial methodology, pharmacology basics, statistical basics, office software proficiency, Portuguese fluency, English (intermediate to advanced)
Preferred skills
Experience with ANVISA requirements, CEP submission experience, client communication
Technologies
Microsiga, Plataforma Brasil, Pacote Office
Responsibilities
Design bioequivalence study protocols, manage clinical unit pharmacy temperature/humidity and medication preparation, submit protocols to Ethics Committees (CEP), respond to ANVISA inquiries, collect ethical committee opinions, maintain protocol documentation spreadsheets, review scientific literature, coordinate with commercial teams and clients
Seniority
Junior, hands-on IC