Laurie W Mitchell

About Laurie W Mitchell

Master\'s-prepared Clinical Nurse Specialist with 20+ years industry experience in pharmaceutical and medical device research. Medical Writing• Clinical regulatory documents, US and OUS regulatory reports, including Clinical Evaluation reports (CERs), annual reports, Clinical Study Reports (CSRs) and ad-hoc reports for the FDA and other global competent authorities • Investigator brochures (IB), Instructions for Use (IFU), Informed Consent Forms (ICF), protocols, Clinical Investigation Plans (CIP), templates and briefing documents• Common Technical Document (eCTD) and summary submission documents (Clinical Summary of Efficacy, Clinical Summary of Safety and Clinical Overview), IND/NDA submissions and regulatory response documents• DSMB and CEC Charters and reports, safety plans, SOP/DOP development and work instructions• Coordinate internal review of all regulatory reports, reviewing the report scope, statistical output and tables, organization and readiness for submission • Research source documents and write report-quality clinical endpoint narrativesSafety Surveillance• Prepare safety reports for regulatory submissions (MedDev, EU Vigilance Reporting)• Conduct adverse event (AE) review, identify events for CEC adjudication, oversee CEC dossier submission, interface with the CEC regarding event adjudication and review CEC adjudication results• Direct and manage DSMB activities for multiple clinical trials, including review of Statistical Analysis Plan (SAP), preparation of DSMB report and Charter, represent Sponsor at DSMB meetings, conduct training and present study metrics to DSMB during open session meeting

Experience

1. President

   Criterion Edge

   Jan 2016 — Present · San Luis Obispo, CA, US

   Criterion Edge is a focused service provider, delivering medical/ regulatory writing and clinical safety services to the pharmaceutical and medical device industries. The company’s expertise in regulatory writing and safety, honed over decades, utilizes best practice processes, produces superior deliverables, and provides budget, resource and timeline flexibility for clients. Criterion Edge empowers companies to deliver superior health care solutions.

Education

• UCLA

  MN, Master's of Nursing, Critical Care Clinical Nurse Specialist

Skills

• Protocol
• U.s. Food and Drug Administration (Fda)
• Microsoft Excel
• Clinical Trial Management System (Ctms)
• Regulatory Submissions
• Training & Development
• Pharmacovigilance
• Ctms
• Biotechnology Industry
• Good Clinical Practice (Gcp)
• Clinical Trials
• Pharmaceutical Industry
• Fda
• Biotechnology
• Life Sciences
• Microsoft Word
• Gcp
• Clinical Development
• Neurology
• Ich-Gcp
• Medical Writing
• Medical Devices
• Clinical Research