1. Zaid Daniel J Smith, PhD
2463 Breakwater Circle, Sarasota FL 34231
(941) 926-3398 home (941) 993-6099 mobile
zaid@aya.yale.edu
Experience
Freelance medical writing, insured LLC 1991 – present
Clinical/Regulatory
 IND applications and annual reports (clinical and nonclinical sections)
 IBs
 Protocols
 Clinical study reports (Phase 1 through 4)
 NDA Integrated Summaries (ISE/ISS)
 NDA clinical summaries/clinical overviews
 Meeting briefing packages (Pre-IND/End of Phase II/Pre-NDA)
 Orphan Drug and Qualified Infectious Disease Product applications
 Narratives
Medical Affairs/Communications
 Manuscripts for peer-reviewed publications
 Advisory Boards
 Posters, abstracts, slides
 White papers
 HEOR publication
Medical Education
 Current practice summaries
 Meeting coverage
Medical Writer II, Randstad Pharma (staffing Astellas) Apr 2012 – present
—Regulatory writing: pediatric sNDAs (2.2 Intro, 2.5 Clin Overviews, 2.6.2 Pharm
Summaries, 2.7 Clinical Summaries, 2.7.3 Efficacy Summaries, US & Canada),
ph1 CSRs, IBs, INDs, Qualified Infectious Disease Products, Orphan Drug
Designations, pop PK, Briefing documents
Senior Medical Writer, ICON (CRO) Oct 2010 – Apr 2012
—Regulatory writing: NDA (2.2 Intro, ISSs), Proposed Pediatric Study Request, ph 1-3
CSRs, ph1 protocols, narratives
Manager, Scientific Publications, Sirion Therapeutics Jun 2008 – Apr 2010
—Regulatory writing 2 successful NDAs in 1 year: (2.2 Intro, 2.5 Clin Overview, 2.6.2
Pharm Summaries, 2.6.4 PK summaries, 2.7.2 Clin Pharm Summaries, ISSs,
ISEs), ph 2-4 CSRs, Orphan Drug Designations, narratives, briefing documents
—Supported Regulatory, Medical Affairs, Clinical and Marketing with writing and research
—Evaluated the potential for inlicensing of new ophthalmic products
Manager, Scientific Publications, RxDev Resources (CRO) Mar 2006 – Jun 2008
—Regulatory Writing: NDA (2.4 Nonclin Overview, 2.6.6 Tox summary, 2.7.2 Clin Pharm
Summary), protocols, IND (Prev Human, GIP, IB, Pharm-tox), Informed Consent
Forms. Rx Dev Res became Sirion Therapeutics.

2. Zaid Daniel Smith, PhD
2
—Medical Affairs: posters, journal articles
Chief Writer, FMQIA (QIO) Apr 1998 – Dec 1998
—Journal publications, Medicare research initiatives, Annual Reports, press releases
Sr Health Technology Analyst, ECRI Institute Apr 1993 – Sept 2003
—Detailed technology assessments and pharmacoeconomic/cost-effectiveness analyses
Research Analyst, DataTactics Jun 1991 – Jan 1992
—Market research reports
Education/Research
PhD, Neuroscience: University of Virginia, Charlottesville, VA
MS, Psychobiology: University of California Irvine, Irvine, CA
BA, Psychology: Yale University, New Haven, CT
Associate Researcher, Yale Cell Biology
Asst Prof, UT Southwestern Internal Medicine (Nephrology)
Researcher, HHMI UT Southwestern Dallas
Grad course in pharmacoeconomics at Jefferson Medical College (with David Nash)
Grad course in meta-analysis at Temple University (with Ralph Rosnow)
Environments and Software
Livelink, SharePoint, Documentum, Acrobat, Office, Photoshop, RefMan/Endnote/ProCite,
ISI
Publications
Peer-reviewed publications and health care technology assessment reports, upon request.
Experience with: cardiology, dermatology, endocrinology, genetic medicine,
gastroenterology, hematology, immunology/allergy, infectious disease, internal
medicine, interventional radiology, neonatology, neurology, obstetrics/gynecology,
oncology, ophthalmology, orthopedic surgery, pediatrics, pulmonology, thoracic surgery,
urology, vascular surgery