Medical Affairs-Clinical Affairs Mission Note

• To apply my extensive experience as a medical director, assistant medical director and senior global medical adviser for medical affairs departments which I have gained from my training and working for several biotechnology, pharmaceutical and medical device companies in which my projects specifically involved therapeutic agents to include oncology, gastroenterology, dermatology, upper respiratory, dermatology, orthopedics-rheumatology /orthopedic trauma, vascular, wound healing, cardiology, neurology and gastrointestinal pharmaceutical therapeutic agents-medical devices. I am strategically located on the U.S. eastern seaboard near a major airport as this has played a key role in my successful medical affairs activities.
• I am personally interested in this therapeutic area as I see the value of patient outcomes as my father's life was extended an additional 15 years due to novel oncology therapeutics and gastrology therapeutic.

Medical Adviser-Liaison Medical Affairs-Clinical Affairs Objective Note

• As a medical director and assistance medical affairs director, I have had the pleasure of performing medical writing for several pharmaceutical-biotechnology companies working specifically on several oncology projects that have impacted what is most important to me which is improving the wellbeing of patients. Specifically, I have worked with oncology advisory boards selected by Roche for two important therapeutic treatment areas which include colorectal cancer and breast cancer. I worked on development of advisory boards and KOL selection by Roche for their colorectal cancer agent CME programs and their breast cancer CME programs featuring updates from ASCO.
• In addition, I have worked with medical education companies associated with Shire Pharmaceutical Company for CME/CE KOL programs for the management of ulcerative colitis. This program was performed in conjunction with the John Hopkins University School of Medicine with the API Mesalamine, Balsalazide, Sulfasalazine and Immunomodulators. Specific are of concentration for this project was focused on the use of ACG guidelines for treating mild to moderate ulcerative colitis.
• I have traveled to all fifty states and functioned as the medical moderator, medical compliance officer and medical writer with the selected oncology KOL team selected by Roche and OrthoBiotech. These presentation included attending departmental briefing meetings within over 300 hospitals, conducting over 1000 teleconferences/webinar seminar with these selected KOL's which included dinner meetings.
• In addition to these programs, I have worked on similar designed programs with OrthoBiotech for their therapeutic agent used for Ovarian cancer. I worked on development of advisory boards and KOL selection by OrthoBiotech for the delivery of these CE programs nationwide as the medical moderator-medical compliance officer.
• As a medical director, assistant medical director for medical affairs, I have managed the complexities of this position with both large and small pharmaceutical companies and biotechnology companies. During my medical affairs position work, I hired, mentored and developed team members to work with me as I developed strategies for global marketing, global clinical studies pre-clinical thru phase IV, post marketing studies regulatory document compliance review, promotional material review, global launches legal review, consumer care, R D drug delivery system review/ literature research, clinical study protocol review, informed consent review, establishing field based MSL teams, field based clinical liaison teams, developed field based medical literature/PowerPoint presentations for field based use of FDA approved products along with different stages of clinical trial activity presentations and evidence based medical communication delivery strategy plans.

Confidential

• Conducted technical laboratory experiments for research on infectious disease that cause respiratory dysfunction.
• Conducted technical laboratory experiments for research on Entamoeba Histolytic:
• Genetic control of susceptibility in chicken eggs, Dr. Katherine Cook Jaouni.
• Primary structural evidence that the H-2DQ region encodes at least three distinct gene products: DQ, LQ and RQ. Dr. Eric Lillehoj Molecular Immunology, Volume 21, Number 3, pages 185-190, 1984 , Amino Acid Sequence Analysis of the H-2KK
• Alloantigen: Complete Sequence of Residue 1-98 and Partial Sequence from 99 to
• 263. Dr. Eric Lillehoj Molecular Immunology, Volume 21, Number 3, pages 185-
• 190, Analysis of the membrane structure of murine H-2 histocompatibility
• antigens by employing radiosequence analysis technology. Radioactive
• protein chemistry Radio-Labeling Cells protein separation columns,
• establishment of tumor cell lines, tissue culture techniques, high
• performance liquid chromatography, hybridization of cells, tryptic peptide
• mapping techniques.

SUMMARY OF CLINICAL RESEARCH SKILLS

DoD Department Of Defense Medical Chart Reviewer Public Trust Clearance Classified

DoD Department Of Defense Senor FDA Consultant Analyst/Medical Writer

DDMAC Reviewer

Senior Global Medical Adviser

• Critical Analysis Clinical Expert Report Developer
• Clinical Trial Data Extraction Manager
• Scientific Review Officer, Scientific Review Manager, Project Manager
• Scientific Review Administrator
• Clinical Medical Monitor/GCP Auditor
• Assistant Director for Medical Educations
• Podiatric Medical Director
• Medical Moderator
• Associate Podiatric Medical Director
• Medical Information Specialist
• Medical Science Liaison
• Medical Advisor / Medical Liaison
• Medical Writer/ Technical Writer
• Pharmaceutical review committee participant
• Medical Device review committee participant
• Pharmacovigilance Monitor
• Medical Lecturer
• Adverse Event Monitor / Reporter
• Medical Case Reviewer
• Clinical Research Associate/GCP Auditor
• Medical Content Developer / Editor
• Safety Reviewer/ Safety Associate
• Medical Training Consultant
• Data Reviewer
• Medical Chart Reviewer
• Medical Education Seminar Developer
• Medical Education Program Developer
• Pharmaceutical Educational/CME Seminar Content Developer/Presenter Consultant
• Assistant Medical Director for Sepsis and Cardiovascular Biomarkers Medical Education Programs United States/ Germany
• Oncology Biomarkers
• Senior Analyst Expert FDA
• Laboratory research assistant National Institutes of Health Laboratory of Infectious Diseases and Laboratory of Immnunogenetics