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Skills

  • Expert knowledge of clinical trial phases
  • Budgets
  • Regulatory compliance
  • Document workflow optimization
  • Medical literature analysis
  • Leadership of writing teams
  • Supervision
  • Healthcare product lifecycle knowledge
  • Document version control
  • Patient safety narrative drafting

Work Experiences

  • Acted as a compliance advocate during regulatory meetings with system, ensuring written documents adhered to the highest ethical standards.
  • Acted as a compliance advocate during regulatory meetings.
  • Placed a high value on punctuality and worked hard to maintain an excellent attendance record, consistently arriving at work ready to work right away.
  • Pushed for operational changes that resulted in cost savings and higher profit margins.
  • Conducted research and compiled statistical data in order to support cost-cutting and quality-of-care initiatives.
  • Collaborated with internal and external stakeholders.
  • Achieved market entries within 2 months.
  • Authored detailed clinical study synopses that accentuated the trial outcomes and facilitated better decision-making for 7 key stakeholders.
  • Pulled patient records accurately for upcoming appointments and procedures, usually within 6 hours.
  • Used email and the phone to communicate effectively with staff, patients, and insurance companies.

Summaries

  • Accomplished Senior Medical Writer.
  • Recognized on a regular basis for outstanding performance and contributions to the Miscellaneous industry's success.
  • Dedicated professional in clinical research communication.
  • Accomplished in writing and editing peer-reviewed manuscripts and increasing publication acceptance rates by 43% in top-tier journals.
  • Achieved 58% improvement in submission timelines.
  • Cut down unnecessary costs.
  • Excited and dedicated to accuracy, with excellent decision-making abilities.
  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.
  • Accelerated submission approvals.
  • Authored regulatory documents.

Accomplishments

  • Led development of 3 manuscripts from Phase I-IV clinical trials, resulting in publications within high-impact medical journals within Miscellaneous.
  • Provided medical writing support for process registration, leading to category, including recognition by metric.
  • Managed and directed the submission of multiple scientific communications, with publication rates increasing by 79% at category.
  • Collaborated with biostatisticians to ensure correct interpretation of statistical data in clinical reports, reducing review iterations by 46%.
  • Applied system to streamline document workflows and version control, reducing manual errors by 72% and improving submission timelines.
  • Mentored and managed 12 medical writing specialists, improving document accuracy rates by 55% year-on-year.
  • Documented and resolved standard which led to category.
  • Provided writing expertise for Protocol Development Working Group within system, leading to enhanced precision and alignment with FDA guidelines.
  • Developed publication strategy resulting in 51% increase in abstract submissions within 2015, boosting departmental and company visibility in system.
  • Implemented standardized document templates within ServiceNow, resulting in a 81% decrease in document preparation time for clinical studies.

Affiliations

  • American Medical Writers Association (AMWA)
  • Graduate of the Medical Communications Certification Program by category
  • National Association of Social Workers
  • European Medical Writers Association (EMWA)
  • Society for Clinical Research Sites (SCRS)
  • Team leader for clinical documentation improvement committees at Vantage
  • Founder of a peer-review group for improving clinical manuscript quality at Columbus
  • Society of Women Engineers
  • Speaker at standard focusing on medical writing for regulatory submissions
  • Association for Computing Machinery

Certifications

  • Certified Public Accountant
  • ServSafe
  • CompTIA Network+
  • Cisco Certified Network Associate (CCNA)
  • CompTIA Security+
  • Advanced Medical Writing Training: FDA and EMA Submissions - Ironclad Systems
  • Certified Professional Medical Writer (CPMW) - 2020
  • Cisco Certified Internetwork Expert (CCIE)
  • Google Certified Professional Cloud Architect
  • Clinical Data Interpretation Certification - Vantage

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