Medical Information Scientist or Medical Affairs Writer or Staff

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    JAN MICHAEL KITZEN 325 Sonnet Lane - Collegeville, PA 19426 - 610.489.4965 - [email protected]

    PROFESSIONAL QUALIFICATIONS

    Driven and detail-oriented professional with over 20 years of experience in leading clinical research, providing medical and scientific support for pharmaceutical products and developing unique approaches to creativity, knowledge acquisition, problem solving, and improving efficiency. Possesses outstanding organizational, program development and management, and written and oral communication skills along with a successful track record of promoting teamwork and collaborationfrom both internal groups and external partners. A proven leader and medical information specialist who is familiar with various software applications used inthe medical industry. Additional areas of expertise include:

    Regulatory Compliance - Research & Development - Parenteral Product Compounding- Legal Support & ConsultingTeam Facilitation - Presentations - Data Analysis & Interpretation - Training -Management - Quality AssurancePolicy & Procedure Development - Proposal Preparation - Event Planning - Writing(Medical & Marketing)

    EDUCATION & LICENSES

    Ph.D. in Pharmacology, THE UNIVERSITY OF IOWA MEDICAL SCHOOL (Iowa City, IA)B.S. in Pharmacy, TEMPLE UNIVERSITY SCHOOL OF PHARMACY (Philadelphia, PA)Iowa License #14235 (expiration date: 05/2010) - Pennsylvania License #RP041300R (expiration date: 09/2010)

    SELECT CONTRIBUTIONS

    * Played a key role in saving Wyeth Pharmaceuticals significant costs (hundredsof millions) and time for products involved in litigation; increased sales of marketed products; and enhanced productivity in Global Medical Communications-Neuroscience support. Worked directly with health care professionals to answer questions regarding Wyeth's key neuroscience products such as Effexor XR(R) (venlafaxine) and Pristiq(R) (desvenlafaxine).

    * Successfully provided medical and scientific information to health care professionals, including physicians, nurses, and pharmacists. Operated a medical information booth at a major medical meeting for Wyeth's neuroscience products; reviewed and collected comments related to labeling and patient information.* Organized and co-hosted several large scientific meetings, with 100 to 200 attendees; planned the logistical needs of the meetings. Arranged for the publication of presentations at a meeting as a Guest Editor for Drug Development Research.* Served as team leader for a New Drug Application (NDA); managed and coordinated interdepartmental personnel efforts required for NDA preparation. Authored the complete pharmacodynamic and pharmacokinetic portions of the NDA.* Prepared numerous documents, including scientific reports, clinical study reports, white papers, scientific publications, regulatory writing, standard operati

    ng procedures, legal documents, and marketing support materials, over the years.* Designed and developed several experimental models of cardiovascular disease for the purpose of discovering and developing new chemical entities for the treatment of hypertension, myocardial ischemia, and coronary thrombosis.

    PROFESSIONAL HISTORY

    SQA PHARMACY SERVICES (Philadelphia, PA) March, 2010 to PresentTemporary Staff Pharmacist-Retail Pharmacy;Enters prescriptions into the computer system; fills prescriptions, verifies prescriptions filled by pharmacy technic

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    ians, and facilitates the successful and accurate dispensing of medication. Contacts health care providers and insurance companies as required for filling prescriptions. Counsels patients on the appropriate use of medications.

    WYETH PHARMACEUTICALS - acquired by Pfizer (Collegeville, PA) 2006 to 2009Principal Scientist / Associate Director-Global Medical Communications (Neuroscience)Summarized key medical articles related to Wyeth neuroscience products for distribution to clinicians, company executives, and global affiliates. Prepared andupdated (according to FDA changes) scientific response letters and product dossiers for health care professionals. Created documents, slides, and other materials for the launch of a new antidepressant.* Created two new databases to support future neuroscience products; updated andsupervised the proper maintenance of literature databases, both hard copy filesand electronic databases. Contributed to related training material development.* Performed critical analysis of toxicology literature as it pertains to the safety of antidepressants in support of Wyeth's products in Great Britain. Createda database that included ~100 central nervous system drugs and how the Fatal Toxicity Index (FTI) parameter is not always a reliable predictor of human toxicity.* Recognized with the "Exceptional Achievement Recognition Productivity" (team)award for outstanding contribution to the Global Medical Affairs Neuroscience Team in 2009.

    WYETH RESEARCH (Collegeville, PA) 1997 to 2005Director-Clinical Science, 2005 / Associate Director-Clinical Science, 2001-2004Assistant Director-Clinical Science, 1998-2000Recruited to a newly formed task force, the Clinical Science Division, which wasresponsible for providing all scientific, clinical, and literature support to defend the company in three drug product injury litigation cases. Created medical information databases for use in product-injury litigation cases (different products: drug #1, #2, and #3). Produced summary documents, white papers, and literature extracts along with tables of data for use by external counsel and an external panel of experts. Performed critical evaluations of plaintiff's science.Supervised team members in information gathering and ensured all documents wer

    e scientifically accurate. Attended scientific meetings and prepared detailed trip reports to disseminate information to other members of the clinical sciencedivision as well as external counsel. Assisted in preparing class action documents.* Greatly reduced the time required to identify important information by creating searchable literature databases.* Saved the company (and other companies) hundreds of millions of dollars in potential injury claims by hiring a pharmacokineticist and providing sufficient evidence to convince the court judge that much of the plaintiff's science was inadmissible in court (Drug #3)-discredited several scientific papers used by plaintiff expert witnesses.* Minimized the company's financial obligations (Drug #2) through efforts that led to the decision by the court to deny class action status for this particular

    drug.* Helped identify fraudulent claims through efforts of translating the final court-approved version of the class action suit language into algorithms-allowing all submitted cases to be analyzed by computer (Drug #1).

    WYETH-AYERST RESEARCH (Radnor, PA) 1995 to 1997Scientific WriterAuthored clinical study reports required for the submission of New Drug Applications (NDA). Prepared drug safety updates and investigator drug brochures. Coordinated efforts and prepared sections of NDAs. Planned international collaborat

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    ions between Wyeth, USA and affiliates in Europe to meet corporate deadlines. Assisted in new software implementations.* Functioned as the project leader for preparing the zaleplon (Sonata(R)) NDA; scheduled meetings and assigned deadlines to multiple therapeutic divisions to complete all required documents. Successfully met all deadlines related to the submission of two New Drug Applications, for Sonata(R) and Effexor XR(R).

    RHONE-POULENC RORER (Collegeville, PA) 1991 to 1994Section Manager, Cardiovascular BiologyManaged two laboratories involved in discovery and development of new drugs forthe treatment of hypertension and myocardial ischemia. Developed new experimental models for preclinical evaluation of new chemical entities. Trained laboratory personnel. Ensured compliance with FDA regulations. Analyzed experimental data for study reporting.* Generated significant cost savings by learning new models of ischemia (that used small animals) from colleagues at local medical schools. Also developed andperformed new assays to support ischemia studies as well as developed and validated alternative methods for measuring regional blood flow in collaboration withresearchers from the University of Pennsylvania School of Medicine.

    Additionally appointed as an Adjunct Associate Professor of Pharmacology at Temple University Medical School from 1990 to 2000; and reappointed in 2008.

    Also employed in various pharmacist (temporary, intern, and extern) roles at Sou

    theastern Pennsylvania Veterans Center, Integrated Pharmacy Systems, Medical College Hospitals, Elkins Park, Medical College of PA, Walter's Pharmacy, SomersetMedical Center, and Rolling Hill Hospital.

    Prior to 1991, served as a Research Scientist (Wyeth-Ayerst Research), ResearchFellow (University of Michigan), and Clinical Research Associate, Research Associate, and Senior Research Pharmacologist (Hoechst-Roussel Pharmaceuticals).

    AFFILIATIONS

    Mid-Atlantic Pharmacology Society (MAPS) - Executive Secretary (2009-Present), Councilor (1998-2008), Treasurer, Vice President, and President (1993-1998); Temple University School of Pharmacy-Alumni Board of Directors - President (2010-201

    2), Vice President (2008-2010), Chairman-Awards Committee (2003-2008); AmericanPharmacists Association - Member (1995-2009); American Society for Pharmacologyand Experimental Therapeutics (ASPET) - Member (1985-Present)