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Professional Experience Medical

Location:
Derwood, Maryland, 20855, United States
Posted:
May 31, 2017

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tel (301) ***-****; fax (866)-***-****

cell (301) 760-431

e-mail ac0koo@r.postjobfree.com

SUMMARY

Medical writer with Ph.D. and 20 years diverse experience in the pharmaceutical industry including but not limited to the following therapeutic areas: antifungal, anti-infective, attention deficit disorder, anti-inflammatory, antiviral, estrogen agonists/antagonists, cardiovascular, cardio renal, depression, gout, epilepsy, gastroenterology, pain, oncology, platelet reducing agents and schizophrenia.

IND preparation, IB preparation

NDA/eCTD submission documents including pharmacokinetic, bioanalytical reports

Preparation of Clinical Protocols

Final Study Reports (FSRs)

Package Insert preparation

Medical Information Collaboration with Marketing Initiatives

CMC documents including stability reports and assay validation

Authored FDA briefing documents for meetings

PROFESSIONAL EXPERIENCE

Consultant/Contractor BioPharm Global, Inc.

April 2000-Present Gaithersburg, MD

Founded BioPharm Global Inc., a consulting firm specializing in medical writing involving regulatory submissions, pharmaceutical development, marketing, sales training and promotional material. Clients include Astra Zeneca, Cephalon, Eisai, GE Healthcare, NIH, Sanofi Aventis, Shire Pharmaceuticals and Wyeth. Additionally I have worked as a contractor intermittently for 3 years with Image Solutions on eCTD Documents

Authored Investigator Brochures for IND submissions in accord with ICH guidelines, INDs and clinical protocols.

Prepared CMC documents for CTD i.e. Module 3.2 Drug Substance and 3.2P Drug Product and IND Sections.

Prepared Final Study Reports (ICH-E3) for FDA submissions using Word customized shells and macro templates.

Completed synopsis report requested by FDA concerning comparison of adult-pediatric pharmacokinetic exposure information from 5 clinical studies in the field of neuropharmacology.

Authored summary “Human Pharmacokinetics and Bioavailability” of a Neuropharm NDA submission.

Authored sections of package inserts, which was submitted to FDA.

Completed adult pediatric comparison pharmacokinetic report concerning thrombocythemia in pursuit of pediatric exclusivity.

Authored summary sections of eCTD e.g. Summary of Biopharmaceutic Studies (Section 2.7.1), Summary of Clinical Pharmacology (Section 2.7.2), Clinical Efficacy (2.7.3) and Clinical Safety (2.7.4).

Created technical report format (and first technical report) for VC Company suitable for regulatory filing.

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Head Biopharmaceutics Shire Laboratories, Inc.

1996-April 2000 (formerly Pharmavene, Inc.)

Rockville, MD

Prepared prelaunch literature for Carbatrol ® (epilepsy).

Collaborated with marketing groups on preparation of promotional material and formulary applications.

Prepared posters and manuscripts for publication; reviewed/edited contract writers manuscripts.

Presented a poster at international neurology meeting.

Prepared medical information literature relating to patient compliance with dosing regimen.

Involved in clinical protocol design and reviews.

Authored and submitted, edited pharmacokinetic, bioanalytical and Final Study Reports (ICH E3) to the FDA.

Associate Director Biopharmaceutics (promoted to Director See above)

1992-1996 Pharmavene

Rockville, MD

Authored a completer set of standard operating procedures pertinent to clinical pharmacology.

Involved in authoring, editing and submission of Final study Reports (ICH E3) and NDA reports such as pharmacokinetic and bioanalytical reports to the FDA .

Authored and submitted manuscripts for publication in scientific journals.

Principal Research Scientist Schering Plough Research

1991-1992 Kenilworth, N, J

Involved in the physical and analytical specifications of new drug substances (NCE) within a GMP environment.

Performed stability testing according to SOPs and updated CMC drug stability reports with a view to FDA filing.

Evaluated new methodology suitable for CMC stability testing of drug formulations and submitted

Reports to the FDA.

PERSONAL

U.S. status: citizen

PROFESSIONAL AFILIATIONS

American Medical Writers Association

American Association Pharmaceutical Scientists

EDUCATION

University of Strathclyde, Glasgow, Scotland, PhD, Medicinal Chemistry

University of Waterloo, Waterloo, Ontario, M.Sc

Royal Institute of Chemistry, London, England G.R.I.C.



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