Cumulative total of 10 years as a technical writer. Strengths include exceptional organizational ability, flexibility, and innovative problem solving. A quick learner with excellent communications skills, proactive and self-motivated.
Several years experience working within 21 CFR Part 11 (ER/ES) in a pharmaceutical environment. Experienced with Computer System Validation (CSV), project presentation, reports for regulatory submission, and training documentation (both computer-based and hardcopy). Created validation documentation for application service protocol (ASP), commercial off-the-shelf (COTS) and in-house developed systems. Authored training manuals relating to various systems in business, pharmaceutical and government fields. Worked closely with subject matter experts (SMEs) and systems analysts to complete documents. Conducted meetings to gather content and review documentation. Experienced with using active and passive voice to explain complex technical concepts to audiences of various backgrounds. Trained in several document management packages such as Documentum, WebTop, and Remedy. Worked within a Six Sigma environment for 2+ years.
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