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Skills

  • Clinical Trial Document Review
  • Supervision
  • Documentation for Risk Management
  • Process improvement
  • Data-driven process improvements
  • Global Regulatory Knowledge
  • Category equipment
  • Product lifecycle management
  • Adverse Event Reporting
  • Corrective action planning

Work Experiences

  • Accelerated the approval process by 45%.
  • Achieved completion ahead of deadline by 66%.
  • Advocated for process improvements that resulted in a 37% decrease in the review timeline without sacrificing quality standards.
  • Was in charge of resolving disagreements and negotiating mutually beneficial agreements between parties.
  • Achieved no major findings.
  • Discovered new ways to improve the management of medical records.
  • Looked for industry trends on social media and through online sources.
  • Easily interacted and communicated with department personnel and the general public.
  • Chaired weekly review meetings with multidisciplinary teams ensuring safety assessment completion ahead of deadline by 61%.
  • Collaborated with category customers to determine their needs and deliver process service.

Summaries

  • Collaborated with cross-disciplinary teams.
  • Addressed critical documentation gaps.
  • Excited and dedicated to accuracy, with excellent decision-making abilities.
  • Dedicated to learning, growing, and succeeding in Miscellaneous.
  • Consistently exceeded regulatory submission deadlines.
  • Conducted detailed clinical protocol assessments.
  • Achieved approvals for Tableau without financial or safety penalties.
  • Adept at assessing safety data.
  • Collaborative Medical Reviewer excelling in clinical protocol review.
  • Accomplished Medical Reviewer with extensive experience in collaborating with data management teams to resolve coding errors in clinical databases. Consistently met submission deadlines and provided expert feedback to ensure accuracy.

Accomplishments

  • Updated and streamlined medical review SOPs, improving overall operational efficiency by 69% and reducing review turnaround time by two years.
  • Advised clinical teams on data consistency requirements for trial phase reporting, significantly optimizing output accuracy by 55%.
  • Responsible for overseeing the medical review for 11 clinical trial studies, ensuring all protocols adhered to established ICH and FDA guidelines.
  • Assessed cumulative safety data and contributed to 10 pivotal decision points for drug development pipelines, ensuring patient-first outcomes.
  • Performed expedited reviews of clinical trial documentation, contributing to the accelerated submission and approval process of Jira.
  • Co-authored regulatory submissions leading to timely approval of 13 new drug applications (NDAs) within 6 months.
  • Collaborated with global regulatory bodies, ensuring alignment with the latest drug safety legislation, resulting in 14 regulatory-compliant reports.
  • Implemented new training modules on GCP compliance and review methodologies, reducing review processing time by 54% and enhancing reviewer skillsets.
  • Utilized expert knowledge of drug labeling requirements to recommend updates, aligning reporting accuracy and market compliance for 6% of products.
  • Conducted in-depth analysis of adverse event reports, discovering a previously unrecognized drug safety signal that led to metric.

Affiliations

  • Freemason
  • American Academy of Clinical Toxicology (AACT)
  • Good Clinical Practice (GCP) Advisory Council
  • Medical Writing Certification Program (MWCP)
  • International Society of Pharmacoeconomics and Outcomes Research (ISPOR)
  • American Society for Clinical Pharmacology and Therapeutics (ASCPT)
  • Society of Women Engineers
  • American Marketing Association
  • International Conference on Harmonisation (ICH) Compliance Task Group
  • American Medical Informatics Association

Certifications

  • CompTIA Security+
  • Certified Regulatory Compliance Manager (CRCM) - program
  • Certified Public Accountant
  • ISO 13485:2016 Medical Devices - Quality Management Certification
  • Project Management Professional (PMP)
  • CompTIA Network+
  • ISO 14155:2011 Certification for Clinical Investigation of Medical Devices - method
  • Clinical Data Management Certification - standard
  • Good Clinical Practice (ICH-GCP) Certification - initiative
  • Certified in Drug Development and Discovery Management - 2018

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