Resultados de la búsqueda: 9 vacantes
...Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study/program plans and the drug development process.
Qualifications
What we’re looking for
• Bachelor’s...
$71,820 - $139,600 por año
...intelligence.
o Understands applicable local, national, and regional regulations and translates them into organizational best practices.
o Documents the interpretation in a standardized format within the Regulatory Intelligence System in line with implemented procedures...
...data models, schema diagrams, and standard operating procedures.
· Stay up-to-date with the latest Oracle technologies and best practices
· Review and validate solution design and ensure it covers all the technical aspects
· Coordinate with the offshore teams on the...
...data models, schema diagrams, and standard operating procedures.
· Stay up to date with the latest Oracle technologies and best practices.
· Review and validate solution design and ensure it covers all the technical aspects.
· Coordinate with the offshore teams on...
...site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide...
...at an account/project level.
Complexity
Solves complex problems and/or conducts complex analyses. Translates concepts into practice.
Escalates issues to Corporate Quality leadership when required.
Makes decisions that impact a range of standard and non-standard...
...matters as appropriate.
• Advises internal teams on the application of drug and device laws and regulations, as well as Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and Good Pharmacoepidemiology Practice (GPP) as well as Good Manufacturing Practice (...
...management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide...
...degree or RN in a related field or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements.
• Must demonstrate good computer skills and be able...
