TRABAJO REGULATORY AFFAIRS STUDY START

Provides regulatory affairs support during internal and external audits... assists in the development of standard methodologies for regulatory affairs processes...

Demonstrate compliance with all applicable company, regulatory and country requirements... communicate local sites approvals to study team members and stakeholders...

Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence providing guidance and support to study teams...

Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondenceproviding guidance and support to study teams...

Job description the specialist/senior specialist, study start up and regulatory is responsible for completing study start-up and regulatory deliverables based...

Understand chemical and product regulatory compliance... identify and troubleshoot regulatory data issues... qualifications: bachelor's or master's degree in relevant...

study team meetings, monitors’ meetings, investigators’ meetings... • coordinates administrative tasks during the study process, audits and regulatory inspections...

The gsua is a member of the study start-up & site intelligence unit... this may include tasks related to essential document review, regulatory submission preparation...

You will work closely with study implementation teams, as well as clinical operations, data management and regulatory affairs to ensure the solutions meet the requirements...

They are looking for a clinical affairs program manager europe... as part of the global clinical affairs team, you will be responsible for developing strategies...

• participate in blinded review of data packages intended for idmcs • lead a clinical matrix team and ensure patient safety is of paramount importance during the...

Implementation of study amendment-and changes in study related processes)... as required, manages the local study supply... drive study compliance by maintaining...

Implementation of study amendment-and changes in study related processes)... manages local study supply, as required... establishes and maintains excellent working...

Rwe/non-interventional study methods, conceptualize advanced study designs and develop/oversee the development of study protocols and statistical analysis plans...

Excellent understanding of clinical study management including monitoring, study drug handling and data management... supporting/participating in regular qc checks...