With my background in clinical and regulatory submissions for devices, drugs, and biologics as an AMWA-certified medical writer, I am uniquely positioned to make an impact at the drug/device interface, guiding the development of effective regulatory strategy for companion diagnostics (CDx) and combination products. I understand the opportunities and challenges in communicating across multiple regulatory groups simultaneously to bring safe and effective personalized medicines to patients across the globe. My experience supporting this mission includes:+ 4 years in IVD regulatory submissions and strategy to CDRH and to notified bodies+ 2 years in clinical and regulatory submissions to CDER and CBER+ 6 years in scientific publicationsCore Competencies, Medical Device Regulatory Documentation:US:+ PMAs (Full, Modular, Amendments, Supplements)+ 510(k)s+ IDEs, IDE Supplements, Q-Submissions/Pre-SubmissionsCE/ROW:+ IVDR-Compliant Technical Documentation+ IVDD Technical Documentation (using GHTF/IMDRF STED guidance)+ Country-specific submissions for Canada, Australia, South Korea, Japan, and OthersCore Competencies, Pharmaceutical Regulatory Documents+ Briefing documents and responses to RFIs+ NDAs/ANDAs and the eCTD, especially Module 2 and Module 5+ Clinical Protocols, CSRs, and INDs+ IBsAll markets:+ Product labeling and public-facing documentation, especially Instructions for Use and SSEDs/SSPs+ Companion Diagnostic (CDx) IVD Submissions in US, CE, & ROW Markets+ CSRs and Clinical Protocols for IVD and Pharmaceutical Clinical TrialsCore Competencies, Review of Internal Documentation:+ Characterization, Verification, and Validation Studies (records, protocols)+ Scientific Validity Reports+ Clinical Utility Reports+ Clinical Protocols, Clinical Brochures, Investigator Brochures, CSRs+ Deviations, Discrepancies, OOS+ Corrective and Preventative Actions (CAPAs)+ Change Control: Change Impact Assessments and Regulatory Impact AssessmentsCore Competencies, Peer-Reviewed Medical and Scientific Publications+ Original Manuscripts+ Literature Reviews+ Posters and Abstracts+ Presentation slides and scripts