Qualifications

Education

American Medical Writers Association (AMWA) Writing & Editing Core Certificate

Ph. D. in Biochemistry and Molecular Biology Program, Purdue University



B. A. in Biochemistry, Chemistry Dept., University of California, San Diego

Experience

Principal Medical Writer and Owner, Tanager Medical Writing LLC. Current (10 years)
   Senior Medical Writer, PUMA Biotechnology, Los Angeles, CA (7 months)
   Responsibilities: Writing and editing of Clinical Protocols, Clinical Protocol Amendments, DSUR, and Investigator Brochure.

Medical Writer, Vivus, Inc., Mountain View, CA (2 years)
  Responsibilities: Writing and editing of Clinical Study Reports, Clinical Protocols, Protocol Amendments, and Investigator’s Brochures. 
Senior Medical Writer PDL BioPharma, Inc., Redwood City, CA (3.2 years)
  Responsibilities: Writing and editing of Clinical Study Reports, Clinical Protocols, protocol amendments, and Investigator’s Brochures. 
Technical Writer II Abgenix, Inc., Fremont, CA (1 year)
   Responsibilities: Substantive editing of all Process Sciences publications. Project management of all documentation deliverables in close collaboration with scientists. Editing and description of data needed to support manufacturing and contract research.
Technical Writer BD Biosciences Clontech, Palo Alto, CA, (3.3 years)
  Responsibilities: Writing and editing of technical and marketing documents, project management, Catalog Assistant Editor, DNA Vector Database administrator, Technical Communications Coordinator for all protein expression and purification products.
Senior Scientist List Biological Laboratories, Campbell, CA, (3.5 years)
  Responsibilities: Writing and editing of production documentation, product literature, and certificates of analysis; Production scientist at large pharmaceutical company for GMP production of Eye Medication, research and development, and quality control analysis.


Medical Writing and Editing

  • Summarizing Safety Data for a New Drug Application (April 2012) 
  • Global Product Development, AMWA Workshop. (2010)
  • Investigational New Drug Application in eCTD Format, AMWA Workshop (April 2009)
  • Investigational New Drug Applications. AMWA Core Curriculum Course (2006)
  • Development of a Clinical Study Report. Drug Information Association, Professional Development Training course. (January 2006)
  • Tables and Graphs: A Pharmaceutical Approach. AMWA Core Curriculum Course, Asilomar Conference (April 2005)
  • Communicating Results of Routine Clinical Laboratory Tests (April 2011)
  • Sentence Structure and Patterns, AMWA Workshop. (2007)
  • Improving Comprehension: Theories and Research Findings. AMWA Core Curriculum Course. (2006)
  • Outlining for Writers and Editors. AMWA Workshop. (2005)
  • The Drug Development Process, University of California Extension, Santa Cruz. (2004)
  • Editorial workshop, UC Berkeley Extension Journalism Program (2003)

Scientific and Other

  • Clinical Research Training On-Line NIH course (2016)
  • General Principles of Good Clinical Practice (Updated October 2015)
  • Fundamentals of Ethics and Practical Applications (2014)
  • Basics of Epidemiology for Medical Writers (2009)
  • Correlation and Regression Analysis: AMWA Workshop (2009)
  • Statistics for Medical Writers and Editors, AMWA Workshop (2007)
  • Project Management Negotiation Principles and Techniques, UCSC Extension (2007)
  • Annual Reports: SOPs for Developing Content that Meets FDA Requirements (2007) .
  • The Editorial Process at Biomedical Journals: AMWA Workshop (2006)
  • Basic Immunology for Medical Writers and Editors. AMWA Workshop and Fed. Clin. Immun. Soc. (2006)

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