Wanda Reese
University of the Sciences
From Los Angeles, CA
From Los Angeles, CA
EXECUTIVE SUMMARY:
Results oriented/deadline-driven, client-focused professional with over 10 years of experience in various genres of medical writing; broad experience with the drug development process; extensive regulatory compliance knowledge; proven commitment to developing and maintaining strong collaborative relationships; work effectively within multidisciplinary teams and remotely; experienced working deftly across multiple projects, therapeutic areas, within multifunctional teams on overlapping projects, under tight deadlines.
Effective in organizing, critically reviewing, analyzing, and interpreting statistical data for clinical, non-clinical, and scientific documents. Believe in and consistently exercise the use of "best practices" in writing regulatory documents which begins with effective planning/determining process, at the outset of the project.
Follow Wanda
Medical Writer at Jade Medical Communications Group
• 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
December 1997 - Present