Description
SUMMARY: * POST-MARKETING REPORTING: Vast clinical experience in reporting post-marketing events in the pharmaceutical industry. * CDM: Acquaintance on clinical data management, pre-clinical and clinical trials (Phase I, II, III and IV) * CLINICAL WRITING & DOCUMENTATION: Create clinical project documents according to the protocol, including, but not limited to, source documentation forms and guidelines, monitoring Standard Operating Procedures (SOPs), monitoring visit templates and reports. * Knowledgeable in all areas of research including ICH, GCP, CBER, CDER, protocol submissions, on-going regulatory and IND safety reporting. * Project management and relationship management. Excellent written and verbal communication skills. * Sound knowledge in biological terminology, mechanism of action of drugs, organ systems and medicinal chemistry. * Analyze, index and coding of patent technical content in Derwent World Patents Index (DWPI) for business planning and development or for protecting the innovations of our client organizations.
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