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EXECUTIVE PROFILE
A highly qualified regulatory professional that combines education, biomedical and pharmaceutical
regulatory experience, and management capabilities to deliver exceptional results. Demonstrated ability to
manage and coordinate the tasks of multiple complex projects. Special talent for Health Systems
Management. Focus in developing career through continued work in clinical research.
CORE COMPETENCIES
PROFFESIONAL EXPERIENCE
Monitor and coordinate multiple research projects for the Hematology Disease Team in order to
assess the need for and to implement strategies to ensure the conduct of quality research, the
achievement of expected time lines and deliverables, and the efficient use of human and practical
resources.
Coordinate regulatory clinical research activities; Compile and complete materials for submission
to regulatory agencies. Support the development, implementation, publishing and maintenance of
regulatory filings. Provide regulatory advice and provide ongoing support to internal and external
stakeholders’ projects.
Ensures compliance to regulatory requirements, best practices, and ethical standards in the conduct
of research in accordance with Standard Operating Procedures (SOP) and Good Clinical Practice
(GCP).
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Medication Aid Team Lead May 2006- August 2009
Autumn Leaves Retirement and Nursing Home
Managed the medication room activities. Dispersed oral, topical, or intravenous prescriptions in
correct dosages, and assisted residents to adhere to strict medical regiments. Helped create and
maintain Blood-borne Pathogens Exposure Control Plan
Supervised caregivers working different shifts in their daily duties and resolved daily complaints,
concerns and conflicts.
SKILLS
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