Karen A Clossey

*** ******** ***** **** ****, PA 18334 home office: 570-***-**** cell: 570-***-**** fax:

570-***-**** q6itlm@r.postjobfree.com http://www.kacproductions.net (work in progress)

Career Profile

Personable, competent, skilled business professional with Master’s degree (Master of Environmental Health) and a

successful 20+ year track record in the pharmaceutical/biotech/academic arena. u From 1987 2000 I worked as a

Lab Scientist performing molecular biology and protein chemistry techniques in both academia and pharmaceutical

industry and from 2000 current I worked as Clinical/Regulatory/Scientific Writer. Accustomed to handling sensitive,

confidential records. Demonstrated history of producing accurate, timely clinical study reports meeting stringent

regulatory FDA Code of Federal Regulations (CFR) and International Committee on Harmonization (ICH)

guidelines. Have demonstrated proficiency in global regulatory submissions.

Thrive in deadline driven environments. Excellent team building skills. Independent, rapid learner/motivator. Strong

attention to scientific content and format, proven ability to manage several concurrent projects and work

independently.

Skills Summary

Extensive knowledge and compliance with International Committee on Harmonisation ( ICH) and Center for

Biologics Evaluation and Research (CBER) guidelines applicable to Investigative New Drug (IND)

submissions, New Drug Applications (NDA) and Biologics License Applications (BLA)

Extensive Understanding of the FDA Code of Federal Regulations (21 CFR Part 11, 50, 54,210, 211,

312,314, 820) and ICH E3 (Clinical Study Reports), ICH E6 (Good Clinical Study Practice), ICH E2C

(Clinical Safety Data Management Periodic Safety Update Reports for Marketed Drugs) and ICH S7A

(Safety Pharmacology Studies for Human Pharmaceuticals)

Project Management of regulatory documents

Wrote/edited the evidence tables for Health Outcome dossiers

Wrote the CMC Module 2.3 (Overall Quality Summary) and Module 3 (Quality) for renewal and variation

submissions

Wrote Clinical Study Reports (CSRs), protocols, protocol amendments, Investigator’s Brochures (IB’s),

Annual Reports (AR), Product Annual Reviews (PAR), Serious Adverse Event (SAE) narratives, Periodic

Safety Update Reports and Periodic Adverse Event Reports (PSURs and PADERs), clinical & nonclinical

summaries of safety/efficacy in the Common Technical Document (CTD) format for International Medicinal

Product Dossier (IMPD) and Investigational New Drug (IND) applications, Marketing and Reimbursement

dossier

Performed various molecular and protein chemistry techniques

Therapeutic areas of expertise: Vaccines, immunology, oncology, Women’s Health, biologics,

cardiovascular

Trained on the CDISC (Clinical Data Interchange Standards Consortium) data standards

COMPUTER SKILLS: Microsoft Office: Word, Excel, Power Point, Access, Outlook, MS Project, Adobe

Acrobat, Documentum, edm, Sigma Plot, Visio Project

K.A.C. productions, LLC (self-owned, home-based periodic medical writing business since 2007)

Contractor/Client Role/Project Time period

Tunnell Consulting/Pfizer 08/2010 07/2011

CMC Senior Submissions Consultant/ CMC project

Pharmaceuticals Created/edited Module 2.3 (Quality Overall Summary) and

Module 3 (Quality Documents) within the Predict template for

new market variation and renewal submissions

Page | 1

Karen A Clossey

239 Hornbeam Court Long Pond, PA 18334 home office: 570-***-**** cell: 570-***-**** fax:

570-***-**** q6itlm@r.postjobfree.com http://www.kacproductions.net (work in progress)

Contractor/Client Role/Project Time period

Managed the writing and review of the CMC Module 3

sections through the Pfizer manufacturing group while

maintaining deadlines

Ensured timely assembly and submission of the Module 2 and

3 CMC sections to the Pfizer Country Offices (PCOs)

Responsible for the Arthrotec®, Zoloft®, Depo Medrol®,

Cardura®, Neurontin® and Accuzide® new market variation and

renewal submissions

Valspec/sanofi pasteur 10/2009 08/2010

Process Book Designer/Process Book Project

Creating/Constructing Process Book Vaccine Manufacturing

Workflows within an internal web based application

Editing/writing validation protocols/reports and various GMP

production documents

Managing Manufacturing Technology team review of vaccine

process flow fom API to packaged/labeled product

Regulatory Writer/Clinical Trial Project

Laxai/OSR/Harvard Medical 01/2010 03/2010

School Writing/editing sections of a Clinical Study Protocol and

Report for an anti obesity indication

Marc Nichols & 10/2007 12/2007

Regulatory Writer/Clinical Trial Project

Associates/Progenics Edited/QC’d an Investigator’s Brochure and Phase1 Clinical

Pharmaceuticals Trial Protocol

Edited CMC sections of IND/BLA submissions for an

oncological indication

Wrote SAE Narratives for various indications (diabetes,

cardiovascular and sleep apnea)

Health Outcomes Consultant/Dossier Project

Research Triangle Institute 06/2007 10/2007

Wrote the following sections of a Pricing and Reimbursement

Dossier for a US/European marketed rheumatoid arthritis

drug:

Section 5 (Quality of Life)

Section 6 (Health Economics)

Section 7 (Price/Reimbursement)

Professional Experience

Discovery Laboratories, Inc, Warrington, PA 18976 09/2012 current

Senior Manager, Scientific Writing

Created the company style guide/conventions and templates for various clinical regulatory documents

Ensured adherence to company standards for protocols, reports, investigator brochures, and other

regulatory documents

Established and ensured adherence to document preparation timelines

Managed/supervised medical and scientific writing consultants and contractors

Reckitt Benckiser, Richmond, VA 23235 03/2012 05/2012

Clinical Medical Writer

Page | 2

Karen A Clossey

239 Hornbeam Court Long Pond, PA 18334 home office: 570-***-**** cell: 570-***-**** fax:

570-***-**** q6itlm@r.postjobfree.com http://www.kacproductions.net (work in progress)

Created a workflow spreadsheet for the clinical medical writing projects

Edited a single ascending dose with a sublingual lead in arm clinical study protocol for

buprenorphine/naloxene as a subcutaneous implant for the indication of opiate addiction

Edited a multiple ascending dose clinical study protocol for buprenorphine/naloxene as a subcutaneous

implant for the indication of schizophrenia

Edited an Investigator’s Brochure for buprenorphine/naloxene for the indication of opiate addiction to be

submitted to the China Center of Drug Evaluation (CDE)

Incorporated final edits from clinical review team to the clinical study protocol template

RCM Technologies, Parsippany, NJ 07054 11/2011 02/2012

Medical Writer, PV Scientist at Janssen Research and Development LLC, Morris Plains, NJ

Wrote/updated global safety aggregrate reports consisting of Periodic Safety Update Reports (PSURs),

Periodic Adverse Drug Experiences Reports (PADERs), Summary Bridging Reports (SBRs), Abbreviated

Summary Reports (ASRs) and IND Annual Reports for consumer and pharmaceutical products

Responsible for following products:

Codeine/diphenhydramine/ammonium chloride

o

Bromhexine/orciprenaline sulphate

o

o Acrivastine

Assent Consulting, Solana Beach, CA 92705 04/2011 10/2011

CW Medical Analyst III Contractor at Amgen Pharmaceuticals, Thousand Oaks, CA (home based)

Summarized journal and review articles for inclusion into Section 3, Supporting Clinical Evidence of

Academy of Managed Care Pharmacy (AMCP) and Health Technology Assessment (HTA) dossiers

Supported etanercept (Enbrel®), darbepoetin alpa (Aranesp®), epoetin alpha (Epogen®) and

filgrastim/pegfilgrastim (Neupogen® and Neulasta ®) project teams by writing evidence table (ET)

summaries for inclusion into Section 3, Supporting Clinical Evidence, of AMCP and HTA dossiers

Wrote 39 ET summaries: 7 for pegfilgrastim, 2 for epoetin alpha, 5 for darbepoetin alpha and 25 for

etanercept

Wrote portions of Sections 2 (Product Information and Disease Description)and 5 (Other Supporting

Evidence) of AMCP pegfilgrastim and etanercept dossiers

Performed quality control reviews for etanercept AMCP and HTA dossiers

Adhered to AMCP Format for Formulary Submission guidelines, Amgen style guide, AMA Manual of Style,

10th edition, and International Committee of Medical Journal Editors (ICMJE) for clinical and other global

medical writing templates and references

Smith Hanley Consulting Group LLC., Lake Mary, Fl 32746 02/2011 03/2011

Medical Writer Contractor, Autoimmune at Kyowa Hakko Kirin (KHK) Pharma, Inc., Princeton, NJ

Wrote sections of a clinical protocol for a Clinical Trial Application (CTA) for a psoriasis indication

Page | 3

Karen A Clossey

239 Hornbeam Court Long Pond, PA 18334 home office: 570-***-**** cell: 570-***-**** fax:

570-***-**** q6itlm@r.postjobfree.com http://www.kacproductions.net (work in progress)

Read journal and review articles of the ligand/receptor biologic target to write sections of the clinical

protocol

Wrote Section 1 (Introduction and Study rationale) which included summarizing the non clinical reports

Wrote/edited Sections 2 4 (Objectives, Subject Selection and Investigational Plan) with input from the

medical monitor

Trained on the GRAPES template and adhered to all KHK style guidelines/formatting using KHK’s

electronic data management (edm) system

i3 Statprobe, Ann Arbor, MI 48103 01/2009–03/2009

Senior Medical Writer, Medical Writing and Scientific Communication (home based)

Drafted Clinical Summary of Safety (CSS) for a breast cancer indication

MedImmune,Gaithersburg, MD 20877 09/2008 11/2008

Scientific Writer, Senior Submission Writing

Edited/proofread the non clinical IND documents for oncological indications

for Module 2.4 (Non clinical Overview) and Module 2.6 (Non clinical Written and Tabulated Summaries)

and Module 4 (Non clinical Study Reports) of a CTD

Wrote/edited submission ready IND/BLA documents to Regulatory Affairs following the template and

regulatory agency guidelines

Judge Technical Services, West Conshohocken, PA 19428 12/2007 09/2008

Medical Writer Contractor at sanofi aventis, Bridgewater, NJ

Wrote a Phase 3 Clinical Study Report (CSR) to evaluate the efficacy and safety of

telithromycin oral suspension versus azithromycin oral suspension to update to the product labeling for

pediatric use

Updated a Clinical Investigator’s Brochure (CIB) for Phase 1 study for Obstructive Sleep Apnea Hypopnea

Syndrome

Wrote IMPD/IND Clinical Modules (2.5 and 2.7, Clinical Overview, Clinical Pharmacokinetics (PK), Clinical

Pharmacology, Safety and Efficacy, Benefits and Risk Assessment) in CTD format for CTA (EU

submission) or IND (US submission) for cardiovascular and asthma indications

Editing assistance for the CMC and non clinical sections of the IMPD/IND CTD modules for cardiovascular

and asthma indications

Populated a CSR shell for a Phase 1, randomized, double blind, double dummy,

4 period, 4 treatment crossover study for ventricular repolarization

Organized/managed cross functional team review meetings

Submitted documents for final approval and stored final documents within the electronic document

management system

On Assignment Inc, Princeton, NJ 08540 05/2007 10/2007

Regulatory Writer Contractor at Wyeth Pharmaceuticals, Collegeville, PA

Page | 4

Karen A Clossey

239 Hornbeam Court Long Pond, PA 18334 home office: 570-***-**** cell: 570-***-**** fax:

570-***-**** q6itlm@r.postjobfree.com http://www.kacproductions.net (work in progress)

Wrote a Regulatory Response Briefing Document for the China Center for Drug Evaluation (CDE) for an

Asian clinical study for the treatment of vasomotor symptoms (VMS)

Wrote a Phase 1 CSR entitled “The Effect Of A High Fat Meal On The Relative Bioavailability And

Pharmacokinetics Of A Single Dose Of Bazedoxifene Acetate/Conjugated Estrogens (Premarin ® New

Process) for the treatment of menopausal symptoms”

Collaborated on the writing of two Phase 1 CSRs for Bazedoxifene Acetate/Conjugated Estrogens for an

IND Submission

Wrote the Pharmacokinetic/Pharmacodynamic (PK/PD) non clinical and clinical sections of Phase 1 CSRs

for the women’s health therapeutic area

Smith Hanley Consulting Group, Lake Mary, FL 32746 02/2007 03/2007

Senior Medical Writer Consultant at ICON Clinical Research, North Wales, PA

Supported the writing of 12 Serious Adverse Event (SAE) Narratives for a Contract Research Organization

(CRO)

Trained on the writing of Periodic Safety Update Reports (PSURs) and Periodic Adverse Events Drug

Reports (PADERs)

Trained and utilized the ARISg (Adverse Reaction Information System Global) safety database for writing

the PSURs and PADERs

Involved in process improvements for the writing of the PSURs and PADERs

sanofi pasteur NA, Swiftwater, PA 18370 12/2005 02/2007

Manager, Medical Writer

Supported the Respiratory Syncytial Virus (RSV) maternal project by updating/writing the RSV

Investigators’ Brochure (IB)

Supervised freelance medical writers contracted by sanofi pasteur to finalize the RSV legacy reports

Wrote 3 integrated Clinical Study Reports (iCSRs) and managed/coordinated the review of 7 other CSRs

for the RSV project

Supported the Adacel® Polio vaccine 5th dose project by updating/writing the Adacel ® Polio IB, Adacel

Td9707 Long Term Follow up CSR for a BLA submission, Adacel Td517 Protocol Amendment and Adacel

IND Annual Report.

Displayed proficiency in various templates (CSR, IB, protocol, AR)

Organized/managed cross functional team review meetings

Submitted documents for final approval and responsible for storing final documents within the electronic

document management system

Abbott Laboratories, Abbott Park, IL 60064 08/2004 11/2005

Senior Quality Professional

Assigned/responsible for the Abbott Hepatitis (AUSZYME Monoclonal Assay) and HIV 1 and HIV 2

diagnostics kits distributed to various hospitals and clinics

Page | 5

Karen A Clossey

239 Hornbeam Court Long Pond, PA 18334 home office: 570-***-**** cell: 570-***-**** fax:

570-***-**** q6itlm@r.postjobfree.com http://www.kacproductions.net (work in progress)

Managed vendor complaints regarding the hepatitis and HIV diagnostic kits

Wrote the hepatitis and HIV diagnostic kits laboratory investigation testing algorithms/designs for internal

Abbott testing laboratory

Wrote the hepatitis and HIV diagnostic kits investigation final reports

Tracked customer complaints using TrackWise and wrote trending reports for complaints

Reviewed DMF (Drug Master File) for product or batch release issues

Prepared spreadsheets/tabulated summaries of customer complaint issues/resolutions for various

diagnostics kits (HIV, Hepatitis A, B & C,HCG)

Manpower Temporary Services, Gurnee, IL 60030 03/2004 08/2004

Project Manager I at Abbott Laboratories, Abbott Park, IL

Processed Investigation Reports (IRs) designed to determine root cause of product non conformances

(NCRs)

Defined metrics for Investigation and Corrective and Preventive Action (CAPA) process and Failure Mode

Effects Analysis (FMEA)

Prepared/edited Standard Operating Procedures (SOPs) for Investigation and Impact Assessment for

Diagnostic Division of Abbott Laboratories

Mapped Operating Procedures using Microsoft Visio affected by revision to Investigation Procedure

Takeda Pharmaceuticals NA, Inc, Lincolnshire, IL 60069 04/2003 03/2004

QA Documentation Specialist

Created SOPs and/or WIs for new procedures with appropriate Subject Matter Expert(s) (SME)

Revised and edited DRAFT versions of Standard Operating Procedures (SOPs), Work Instructions (WIs)

and Forms

Processed SOP’s into DOCUMENTUM:

Ensured accuracy of operating procedures/instructions/policies imported/promoted into DOCUMENTUM

Worked with IT to implement a DOCUMENTUM improvement plan

Created approval packets to finalize documents for approval

Maintained and ensured paper and DOCUMENTUM database integrity

Taught a Proofreading Workshop as a Certified Proofamatics teacher (PROOFAMATICS Vital Learning

Corporation)

Authored/Developed a Standard Operating Procedure and Work Instruction for Takeda’s “SOP System”

Trained new staff on SOPs, WIs and policies

Trained and utilized the ARISg (Adverse Reaction Information System Global) safety database for reporting

of adverse events

Page | 6

Karen A Clossey

239 Hornbeam Court Long Pond, PA 18334 home office: 570-***-**** cell: 570-***-**** fax:

570-***-**** q6itlm@r.postjobfree.com http://www.kacproductions.net (work in progress)

Supervised/trained a junior QA Document Specialist

Medfocus Consulting Services, Des Plaines, IL 60018 10/2002 04/2003

Medical Writer Consultant at Fujisawa Healthcare Inc, Deerfield, IL

Performed Quality Assurance (QA) and sourced clinical tabulated summaries (ie, individual laboratory

measurements by patient abnormal laboratory listings, listings of deaths, other serious and significant

adverse events), non clinical tabulated summaries (Phase I safety studies to determine NOAEL/LOAEL)

and PK/PD reports

Reviewed/edited portions of Clinical Study Reports (ie, Pharmacokinetics (PK) Reports, Adverse Event

(AE) Listings. Serious Adverse Event (SAE’s) Narratives, PSURs, Case Report Forms (CRF’s), Tables,

Listings and Graphs (TLG’s)

Responsible for documentation flow between the Medical Writing, QA/QC and Regulatory (Submissions)

departments

Compiled references using Vancouver reference style

Assisted in various scanning, pre publishing, editing/proofreading and bookmarking duties for an anti

fungal NDA submissin

Medfocus Consulting

Services, Des Plaines, IL 60018 09/2001 10/2002

Medical Writer Consultant at Eli Lilly & Co.,Indianapolis, IN

Compiled a comprehensive, accurate documentation of therapeutic data standards (eg., Neuroscience,

Immunology, Gynecology, Endocrine/Metabolic, Oncology, Urology, Cardiovascular) used in the electronic

collection, storage and analysis of clinical trial data for compliance with CDISC (Clinical Data Interchange

Standards Consortium)

Developed/drafted and assisted in the creation of data standards to maintain and sustain the electronic

submission of clinical trial data into Eli Lilly’s EDC system (InForm™)

Researched various scientific background material to outline clinical trial data collected (ie.,

instrument/efficacy measurement scales)

Edited unpublished manuscripts

Reviewed Clinical Study Plans, Clinical Study Reports, Clinical Study Protocols, Integrated Safety

Summaries, and Statistical Analysis Plans to write a narrative based on the data collected

Coordinated data standard meeting agendas for review of standards with various Subject Matter Experts

(SMEs)

Wrote Reference and Instruction Manuals for various instrumentation/assay methods

Regeneron Pharmaceuticals, Tarrytown, NY 10591 10/2000 08/2001

Regulatory Affairs Associate

Wrote, proofread and edited scientific data and experimental results for Investigative New Drug ( IND)

submissions

Page | 7

Karen A Clossey

239 Hornbeam Court Long Pond, PA 18334 home office: 570-***-**** cell: 570-***-**** fax:

570-***-**** q6itlm@r.postjobfree.com http://www.kacproductions.net (work in progress)

Responsible for editing/writing Pharmacology/Toxicology and Chemistry, Manufacturing and Control ( CMC)

section of Investigative New Drug (IND) submission

Reviewed/edited portions of Clinical Study Reports (ie, Investigational Plan, Statistical Analysis Plans,

Pharmacokinetics (PK) Reports, Adverse Event (AE) Listings. Serious Adverse Event (SAE’s) Narratives

and PSURs, Inclusion/Exclusion Criteria, SAE narratives, Case Report Forms (CRF’s)

Prepared regulatory documents (ie, Informed Consent and IRB approval packets for initiation of clinical

studies)

Compiled, wrote and edited an Annual Report (AR) for an investigational product

Proofread/reviewed Phase I and Phase II Clinical Protocols for IND Amendments

Prepared a Biologics License Agreement (BLA) outline

Compiled and wrote portions of a Product Annual Review (PAR) for a polysaccharide conjugate [(polyribitol

phosphate (PRP)] of the Haemophilus influenza vaccine

Authored standard operating procedures (SOP's) for PAR

East Tennessee State University, Johnson City, TN 37601 09/1999 09/2000

Research Instructor

Protein purification of preLamin A endoprotease from HeLaS9 cells

Nuclear envelope extract preparation

Radiolabeled, 125 I enzymatic assay for determination of prenylation of prelamin A endoprotease

Educated myself on prenylation processing of proteins

Protein quantification assays: BCA, microBCA, optical density

Instruments used include: Wallac beta counter, Alpha Phosphoimager, Fluorometer

East Tennessee State University, Johnson City, TN 37601 05/1997 09/1999

Research Assistant

Purification of carcinogen binding protein from (Oncorhyncus mykiss) liver cytosol

Protein columns used: hydrophobic interaction, anion exchange, Size exclusion

Techniques used: BCA/Lowry protein quantification assay, ammonium sulfate fractionation, Hydrophobic

Interaction Column Chromatography, High Q Anion Exchange Chromatography, High Performance Liquid

Chromatography (HPLC), Size ExclusionGel Chromatography, gel electrophoresis and gel blotting, UV/VIS

spectrophotometer, ultracentrifugation and gel scanner

Oak Ridge National Laboratory, Oak Ridge, TN 37830 07/1999 12/1999

Quality Assurance Regulatory Editor (Part time home based temporary contract Position)

Reviewed/edited Data Evaluation Reports (DERs) prepared by toxicologists at Oak Ridge and other

independent laboratory reports

Assessment of DER for meeting EPA regulations of the Federal Fungicide, Insecticide and Rodenticide Act

(FIFRA) act for pesticide registration or re registration

Page | 8

Karen A Clossey

239 Hornbeam Court Long Pond, PA 18334 home office: 570-***-**** cell: 570-***-**** fax:

570-***-**** q6itlm@r.postjobfree.com http://www.kacproductions.net (work in progress)

Knowledge of pesticide mechanisms

Organization of projects

Merck Pharmaceutical Inc., Rahway, NJ 07065 05/1995 04/1996

Staff Biochemist (Temporary employment)

Elucidation of the mechanism of echinocandin (anti fungal) drug inhibition on glucan synthase enzyme

Insertion of constructs of the 89 amino acid (aa) loop region of the glucan synthase gene into various

plasmids

Purification of a recombinant 89 aa loop region utilizing two separate protein purification tags (avidin biotin

and glutathione sepharose system)

Characterization of this 89 aa loop region in glucan synthase assay and echinocandin drug binding assay

Bayer Pharmaceutical, West Haven, CT 06516 07/1993 04/1995

Associate Research Scientist

Studied the glucose 4 transporter in relation to its role in diabetes mellitus.

Construction of glucose 4 transporter gene of various lengths downstream and upstream of the promoter

region

DNA Sequencing of glucose 4 transporter constructs and extensive tissue culture (CHO, COS, 3t3

preadipocytes, adipocytes and L6 myoblasts (progenitor muscle cell line)

Transfections into various mammalian cell lines, including CHO and COS cells, 3T3 L1pre adipocytes and

L6 myoblasts

Luciferase reporter based chemiluminescence assay to determine presence/activity of

glucose 4 transporter

Pfizer, Inc, Groton, CT 06340 06/1992 07/1993

Research Assistant VII

Studied Il 1 activation and processing in the cell culturing of J774 cells (mouse macrophage like cell line)

Immunoprecipitation Experiments with anti IL 1 antibody

Performed an in vitro assay for measuring cell production of IL 1 via ICE (interleukin convertase enzyme)

and pulse/chase experiments with 35S labeled enzymatic assays as a marker for IL 1 release from cells

Performed a high through put drug screening using a cell adhesion assay with lymphocytes and human

endothelial cells (HEV's)

University of Chicago, Chicago, IL 60611 12/1989 04/1992

Research Technician

Performed FISH (fluorescent in situ hybridization) and PCR (polymerase chain reaction) for detection of

Philadelphia Chromosome [Chronic Myelogenous Leukemia (CML)] from bone marrow samples

Elucidation of the structure of the interferon (IFN) receptor using an anti IFN antibody

Immunoprecipitation experiments with the anti IFN receptor antibody

Page | 9

Karen A Clossey

239 Hornbeam Court Long Pond, PA 18334 home office: 570-***-**** cell: 570-***-**** fax:

570-***-**** q6itlm@r.postjobfree.com http://www.kacproductions.net (work in progress)

Construction of a cDNA library from a U937 monocytic cell line

Screened a lambda gt11 library to isolate the IFN receptor gene

Ran Southern Blots of various clinical genomic cell lines to isolate and characterize the receptor

Ran DNA sequencing gels, Western Blots, subcloning procedures and plasmid constructions, plasmid

preps and agarose gel electrophoresis

Creative BioMolecules, Inc., Hopkinton, MA 01748 07/1987 11/1989

Research Associate

Purification of the osteogenic protein using: Affinity Chromatography, Size Exclusion Chromatography, TSK

Chromatography, HPLC and gel electrophoresis

Performed an in vivo functional bioassay of purified osteogenic protein

Awards and Additional Training

1987 Biology Award undergraduate research project “Epithelial mesenchymal interactions in initiating

tooth germ morphogenesis and cell differentiation in tissue culture”

1999 Honorable Mention Society of Toxicology (SOT) poster presentation of my thesis

2001 Recipient of the Medfocus Award “In Appreciation of Outstanding Achievement and Service”

2004 Advanced Microsoft Word Certification

2004 Certified Trainer, Proofamatics

2006 AMWA Core Curriculum Certification October 2006

Education

East Tennessee State University, Johnson City, TN

Master of Environmental Health, 1999

Thesis: Purification scheme for a polycyclic aromatic hydrocarbon binding protein in rainbow trout

(Oncorhynchus mykiss) liver cytosol. (SOT Honorable Mention Award 1998)

Graduated Cum Laude (GPA=3.6)

Western Connecticut State University, Danbury, CT

Bachelor of Arts Biology, 1987

Undergraduate Research Project: Epithelial mesenchymal interactions in tooth germ morphogenesis and

cell differentiation in tissue culture

Graduated Cum Laude (GPA= 3.7), Dean's List (1986), Biology Award (1987)

Doctorate courses from Brown University, Rhode Island include: Cell Biology and Immunology

Doctorate courses from University of New Haven, Connecticut include: Biochemistry I and II and Nutritional

Biochemistry

Page | 10

Contact this candidate