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University of the Sciences in Philadelphia has had a rich legacy of producing leaders in science and healthcare since 1821 as the nation’s first college of pharmacy. Dedicated to education, research, and service, USciences has a passion and commitment ...
Jade Medical Communications Group
Medical WriterDecember 1997 - Present• Manage the organization, analysis, writing, editing and reviewing of diverse regulatory & clinical documents including clinical study reports (CSRs), study protocols, investigator brochures, informed consent forms, clinical data summaries and other medical/regulatory documents (including summary documents); FDA Response Letters. Conduct internal team peer reviews of document deliverables according to sponsor guidelines/SOPs including: distribution of drafts, incorporating revisions, and completing sign-off procedures; effective monitoring of trails of document changes, version control. Experienced in relevant electronic document management systems/document editing; team review meetings; working directly with external clients/sponsors in document review/updating. Skill Set: • First-in-Human Studies, PK, Clinical Pharm. • Phases I/II (1a, 2b), III/IV CSR Writing • Patient Safety Narratives(AE/SAE) writing • Document template development • IND and NDA Application Summary Sections experience • QC/QA Review • e-CTD Applications, (Modules 2, 4, 5) • Fluency in FDA, ICH guidance, GCPs • Effective multifunctional team collaboration, overlapping projects/conflicting deadlines management • SOP development, updating • Extensive remote environment experience • Results oriented/deadline-driven, client-focused professional with over 10 years of medical writing experience • Extensive US regulatory compliance knowledge • Work effectively collaboratively/independently and fluidly across multiple projects, timelines, therapeutic areas, functions, and sponsors/clients • Well-versed competency in critically analyzing clinical, technical and scientific data, including the results of clinical research data, and distilling complex concepts into key messages suitable for a variety of regulatory agencies/clinical audiences
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