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Skills

  • Clinical study reporting (ICH guidelines)
  • Patient-facing material development
  • Team building
  • Medical writing for regulatory bodies
  • Records review
  • Healthcare product lifecycle knowledge
  • Content management using standard
  • Document version control
  • DRG assignment
  • Clinical protocol authoring

Work Experiences

  • Ensured that medical records and health information were accurate, complete, and secure.
  • Conducted critical content review of safety narratives.
  • Achieved a 62% reduction in discrepancies during data review.
  • Used email and the phone to communicate effectively with staff, patients, and insurance companies.
  • Acted as a compliance advocate during regulatory meetings with system, ensuring written documents adhered to the highest ethical standards.
  • Accentuated trial outcomes.
  • Collaborated with internal and external stakeholders to create patient-facing materials, resulting in a 57% increase in patient adherence to program.
  • Collaborated with cross-functional teams.
  • Reviewed charts and flagged incomplete or inaccurate information.
  • Saved $8 by putting in place cost-cutting measures that addressed long-standing issues.

Summaries

  • Adhered to high quality standards.
  • Created succinct and engaging regulatory documents.
  • Benefited regulatory stakeholders.
  • Contributed to over 5 successful publications.
  • Created Clinical Study Reports.
  • Benefited patient audiences.
  • Authored regulatory documents.
  • Contributed to 13 abstracts at medical conferences.
  • Accomplished Senior Medical Writer with a proven track record of achieving expedited regulatory approvals across 10 global markets through expert documentation and collaboration.
  • Created regulatory-compliant documents.

Accomplishments

  • Implemented standardized document templates within ServiceNow, resulting in a 81% decrease in document preparation time for clinical studies.
  • Mentored and managed 12 medical writing specialists, improving document accuracy rates by 55% year-on-year.
  • Developed Evidence-Based Medicine (EBM) reports supporting program regulatory filing in the Midwest, earning high accolades for detail accuracy from the metric.
  • Applied system to streamline document workflows and version control, reducing manual errors by 72% and improving submission timelines.
  • Played a pivotal role in the planning and completion of 17 clinical summary documents for submission to procedure.
  • Resolved product issue through consumer testing.
  • Worked with cross-functional stakeholders to deliver 13 abstracts and 14 posters at metric.
  • Provided writing expertise for Protocol Development Working Group within system, leading to enhanced precision and alignment with FDA guidelines.
  • Collaborated with biostatisticians to ensure correct interpretation of statistical data in clinical reports, reducing review iterations by 46%.
  • Developed publication strategy resulting in 51% increase in abstract submissions within 2015, boosting departmental and company visibility in system.

Affiliations

  • Society of Women Engineers
  • European Medical Writers Association (EMWA)
  • International Association of Administrative Professionals
  • Freemason
  • Contributor to medical communication strategy workshops in affiliation with system
  • Founder of a peer-review group for improving clinical manuscript quality at Columbus
  • Member of the American Association for the Advancement of Science (AAAS)
  • Mentor for junior medical writers in association with framework
  • Rotary International
  • American Medical Writers Association (AMWA)

Certifications

  • Cisco Certified Internetwork Expert (CCIE)
  • Clinical Data Interpretation Certification - Vantage
  • Applied Pharmacokinetics and Pharmacodynamics Certification - Harbor & Co.
  • Advanced Writing Skills for Clinical Trial and Regulatory Documents - Harbor & Co.
  • CompTIA Network+
  • ServSafe
  • Introduction to Biostatistics for Medical Writers - Ironclad Systems
  • Cisco Certified Network Associate (CCNA)
  • Responsibilities of Authors and Responsibilities of Editors Certification - Beacon Labs
  • Apple Certified Associate (ACA)

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