Medical Writer

Hana S. Fainman

*** *********** ****

Elizabeth, NJ 07208

908-***-****-Home

858-***-****-Cellular

********@*****.***

SUMMARY: With my experience in the basic sciences, both in the lab and as a

medical writer, I provide preparation of documents for the FDA as well as

editorial consulting services to research scientists, industry, and medical

education companies. My work has appeared in peer review journals, NSF

proposals, as well as approved IND applications.

OBJECTIVE:

Employment within the biotechnology/pharmaceutical industry in the

scope of medical writing

PROFESSIONAL EXPERIENCE:

Medical Writer, Enzon Pharmaceuticals, Inc.

Piscataway, New Jersey

04/2010-Present

Prepare non-clinical study reports on various mRNA antagonist

oncology drugs. Interpret and perform statistical analyses of non-clinical

data. Responsibilities include but are not limited to regulatory

medical writing including the preparation of documents for FDA IND

submissions in eCTD formats including eCTD modules 2, 3, and 4, the QC of

regulatory documents, assisting in preparation of documents in accordance

to ICH guidelines and international regulations. Collaboration with both

non-clinical and clinical teams. Assist in preparation of documents for

business development. Assist in organizing poster presentations

for national and international meetings. Preparation, editing and critical

reading of peer-review articles. Perform relevant Pub Med/MEDLINE

searches.

Technical Writing/Editing, EL-TAS

San Diego, California

07/2008-Present

Conduct revision of proposals and other documents for an engineering

company whose main objective is to develop label-free high-throughput

biochemical sensor for both drug discovery and homeland security.

Provide consultation for translational research of engineering ideas

into clinical research with the long-term goal of drug development.

Consultant, The Endocrine Center

Florham Park, New Jersey

07/2009-09/2009

Conducted literature review and analyses on the effect of conventional

and atypical antipsychotic medications on the induction and

exacerbation of hyperglycemia and diabetes. Findings were presented

in both written form as well as discussion with primary investigator.

Technical Writing/Editing

New York, NY

08/2008-08/2009

Assisted student applying to dental school programs with personal

statement idea initiation and revisions. Writing included description

of the future student's goals as well as summarizing the student's

research experiences and findings. Work involved meeting with the

student in person as well as telecommuting.

Intern, University of Medicine and Dentistry New Jersey, School of

Public Health, Department of Epidemiology and Department of

Biostatistics

Piscataway, New Jersey

08/2008-Present

Internship project studying false discovery rate for gene expression

in microarray data for lung cancer patients with exposures to asbestos

and smoking

Research Associate, University of Miami School of Medicine, Department

of Surgery, Division of Transplantation

Miami, Florida

10/2001-07/2002

Studied the possibility of inducing donor-specific inhibitory activity

in recipient bone marrow utilizing retroviral constructs.

Responsibilities included but were not limited to retroviral

transduction of human bone marrow and PBMC cells, following and

revising existing protocols as needed, interacting with subject

volunteers, presenting data at meetings, presenting findings via

poster presentations, abstracts, and publications.

Graduate Assistant, University of Miami School of Medicine, Department

of Microbiology and Immunology

Miami, Florida

08/1998-09/2001

Studied the function of IL-7R? signaling in vivo

Trained and supervised other lab members

Maintained and organized laboratory

Presented and discussed scientific papers

Presented research findings via written proposals and seminar

presentations

Teaching Assistant, University of Miami

Miami, Florida

01/2000-05/2000

Instructed undergraduate microbiology lab

Volunteer, University of California, San Diego Medical Center,

Department of

Medicine, Division of Pathology/Infectious Diseases

San Diego, California

09/1997-08/1998

Studied chemical and gene therapy approaches to the treatment

of Haemophilus

somnus

Presented scientific papers

Volunteer, University of California, San Diego Medical Center,

Department of

Medicine, Division of Nephrology

San Diego, California

08/1997-08/1998

Involved in a pilot study on the effect of Diltiazem in minimizing

side-effects of Prednisolone in kidney and liver transplant recipients.

Interacted with subject volunteers

Volunteer, HASC Center Inc.

Brooklyn, NY

04/2004-07/2005

Work with elderly patient with mental disorder

TECHNICAL SKILLS:

Proficient in ISIWriter and ISI Toolbox

Proficient in using eDMS

Proficient in MS Office Suite

Working knowledge of Adobe Acrobat

Working knowledge of eCTD format, specifically modules 2, 3, and 4

Familiar with statistical methods utilized in clinical trials

Familiar with computing programs SAS, R, SPSS

Familiar with format of NIH and NSF proposal submissions

Familiar with IRB proposal submissions

Excellent written and verbal communication skills

Thorough understanding of basic science- and clinical- research theory

and methodology

Experience in biochemistry, molecular biology, cell biology,

molecular and cellular immunology laboratory work including but

not limited to: cell isolation, retroviral transduction,

transfection, preparation cell lysate,

immunoprecipitation, SDS-PAGE, Western blotting,

preparation of DNA/RNA, proliferation assays, MOPS electrophoresis,

CTL assay (redirected lysis), ELISA, Southern blotting, Northern

blotting, animal work, PCR, RT-PCR, bacterial culture, flow

cytometry, activity assay using 32P, 51Cr, 125I, 3H

Working knowledge of Unix

Working knowledge of flow cytometry analysis programs: Cell Quest and

WinMDI

Experience working with genomic sequence queries, alignment, and

analysis programs: NCBI, Multiallign, Webcutter,

GeneDoc, BioEdit

Proficient in literature search using PubMed, Medline, as well as

critical reading, editing, and analysis of peer review

publications

OTHER SKILLS:

Proven performance in deadline-driven environment

Demonstrated success in delivering results

Recognized ability to learn quickly and produce immediately

Excellent interpersonal communication skills, team player

Capable of working effectively in both independent and team

environments

Experience in training and supervising

Extensive organizational skills

Fluent in English, Hebrew, Russian

Experience in oral presentations of research findings before an

audience

Ability to utilize audio-visual resources

EDUCATION:

Master of Public Health, Epidemiology

University of Medicine and

Dentistry New Jersey

Anticipated Graduation: May,

2013

Bachelor of Science, Biochemistry and Cell Biology

University of California, San

Diego

Graduation: 1997

RELEVANT COURSE WORK:

Design and Analysis of Clinical Trails Lifetime Data and

Survival Analysis Categorical Data Analysis

Biocomputing

Regression Methods Applied

Longitudinal Data Analysis Chronic Diseases Epidemiology

Advanced Epidemiological Research Methods

PUBLICATIONS AND PRESENTATIONS:

Blomberg BB, Hussini S, Fainman H, et al., Retroviral transduction of

allogeneic class II gene into human bone marrow down regulates allo-

immune reactivity. Human Immunology. 2003; 64:S128

Blomberg BB, Mathew J, Fainman H, et al., Human bone marrow cells

retrovirally transduced with allogeneic class II gene, HLA-DRbeta,

down regulates anti-allogeneic responses of autologous lymphoid

cells. Human Immunology. 2002; 63:S19.

Technical Editing/Critical Reading:

Zhang Y, Casteneda S, Dumble M, et al., Reduced Expression of the

Androgen Receptor by Third Generation of Antisense Demonstrates

Antitumor Activity in Models of Prostate Cancer. Mol Cancer Ther.

2011; 10: 2309-2319.

Patnaik A, Papadopoulos K, Tolcher, A, et al., Phase I Dose-

Escalation Study of EZN-2208 (PEG-SN38), a Novel Conjugate of

Poly(ethylene) Glycol and SN38, Administered Weekly in Patients with

Advanced Cancer. Cancer Chemotherapy and Pharmacology; Paper accepted

03/2013.

Poster Presentation:

American Transplant College (ATC), 07/2002

The Federation of American Societies for Experimental

Biology (FASEB)

American Association for Immunology (AAI), 2002

Abstracts:

Keystone Conference, 2004

The American Society for Histocompatability and Immunogenetics

(ASHI), 2002

American Society of Transplant Surgeons (ASTS), 2002

AWARDS AND HONORS:

Excellent student evaluations for teaching, University of Miami

(06/2000)

Provost's Honor List, University of California, San Diego

(06/1997)

PROFESSIONAL AFFLIATIONS:

American Medical Writers Association

REFERENCES:

Available upon request

Contact this candidate