Description
PROFILE: Motivated, results-oriented Professional with extensive clinical and regulatory knowledge (Good Clinical Practices, Food and Drug Administration, The International Conference on Harmonization and other regulatory requirements), has 16 years experience in clinical support activities with a broad array of clinical database software programs. Possesses exceptional interpersonal skills to develop and foster working relationships with people across all levels of the organization. Exhibits meticulous attention to detail and has strong organizational skills. Significant experience in the pharmaceutical industry, with proven follow through abilities. A Document Management Specialist with experience supporting document control trouble shooting advised and followed up on study progress and compliance within Pharmaceutical and Medical Device industries. * Reviewed all essential documents/contracts to ensure completeness accurate and compliance with applicable company SOPs regulatory and FDA requirements. Support the development review editing and management of controlled documents to ensure accuracy and usability. * Experience maintaining Documentum document management system to manage formula management product specification and clinical research data for document submission processes. * Collaborate with international business units to research compile and manage essential documents for audits and clinical operations. * Support document change control ensuring compliance with document management policies procedures and best practices. * Followed all applicable Standard Operating Procedures and Quality Assurance/Quality Control procedures.
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