Ken D.

Expert-level Regulatory & Process Technical Writer and editor with over 20 years experience, including FDA-regulatory Quality documentation. Highlights: - Draft press release and technical content for advertising and marketing agency clients using SEO methods for Google Search & Apple Search Ads (certified) on AWS and EV topics. - Author 510k submission for NY Medicaid provider and trained/guided staff on QMS management, which included authoring a collection of FDA quality processes and policy. - Draft Teacher’s Notes for Senior Researcher at UVA Darden Graduate School using Standard Harvard Methodology. - Architect knowledgebase wiki using Bookstack for production company. - Wordpress design and web editing / maintenance for independent pharmacy owner clients. - Spearhead HIPAA-compliant Disaster Recovery plan creation for insurance organization. - Prepare drafts for Deloitte Tax clients of submission to IRS for tax incentive program. - Customized Mozilla’s Bugzilla template toolkit to architect an enterprise-scale application; validated for regulatory use; led training sessions via webinars and in-person training sessions for each group based on custom roles and permissions. Recieved award for co-spearheading the design of a brand standards resource; acted as company-wide style czar for all client-facing documentation.