Lavori attuali relativi a Regulatory Affairs Specialist - Milano, Lombardia - Ospedale San Raffaele srl

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Regulatory Affairs Specialist

3 mesi fa

Milano, Lombardia, Italia Ospedale San Raffaele srl A tempo pieno
**Attività principali**:
Supporto per la valutazione di fattibilità di uno studio clinico (disegno dello studio, richiesta locale per procedure specifiche, classificazione IMP e etichettatura...);
Stretta interazione con Comitato Etico;
Gestione della sperimentazione clinica e delle conoscenze dell'Osservatorio (OsSC);
Compilazione Clinical Trial Application (CTA);
Emendamento sostanziale e non sostanziale;
Revisione della documentazione normativa;
Contatto con le Autorità Regolatorie;
Collaborazione con personale locale (clinico, regolatorio, farmacovigilanza);
Supporto al Direttore PT (SCP-OSR)//Unità di fase I per qualsiasi esigenza locale che non sia allineata alla legislazione dell'UE;
Supporto strategico al team clinico e medico per la fattibilità e l'esecuzione dello studio;
Preparazione e sottomissione istruttorie al CE;
Richiesta accesso farmaci in uso compassionevole o expanded access;
Collaborazione alla stesura del protocollo di studio;
Collabora con il Comitato Etico\Ufficio Ricerche Cliniche di OSR;
Supporta ricercatori di base e sperimentatori (interni ed esterni OSR) per rielaborare nuovi protocolli.

**Cosa non può mancare**:
Preferibile Laurea Scientifica e Formazione specifica;
Formazione sulle Good Clinical Practice (GCP);
Conoscenza lingua inglese;
Esperienza nella conduzione di studi clinici sperimentali;
Capacità di prendere iniziative;
Capacità di pensiero critico;
Capacità decisionale;
Capacità nel gestire problemi imprevisti e le emergenze;
Capacità relazionali/comunicative.

**Dettagli lavorativi**:
**Tipologia contrattuale**: contratto di coordinata e continuativa;
Offerta economica commisurata all'esperienza con crescita progressiva;
**Durata**: annuale (fase iniziale) con prospettive di maggior stabilità nel tempo;
**Sede**: IRCCS Ospedale San Raffaele - Via Olgettina, 60 - Milano.