Key Accounting Manager
Current• ICH GCP compliant Clinical Study Reports (CSRs); Phases I to IV, including CSR Synopses for public disclosure• Study Protocols• Clinical and non-clinical sections of the Common Technical Document (CTD) including summaries and overviews for EU or US Regulatory Authorities• Investigator Brochures• Patient safety narratives• Patient information including Informed Consent and Patient Brochures• Pharmacovigilance documents such as Periodic Safety Update Reports• Standard Operating Procedures (SOPs) covering all aspects of drug development including the de-sign, conduct and reporting of clinical trials and the outsourcing of Sponsor responsibilities to a Contract Research Organization (CRO)