MEDICAL WRITING EXPERIENCE

Since April ****:

Freelance Medical Writer

January 2003 – March 2005:

Medical Writer in the Medical Writing Department of ALTANA Pharma (now Nycomed/Takeda), Konstanz, Germany.

I have extensive experience in writing a wide range of demanding medical, scientific, and regulatory documents such as:

• Clinical study reports of clinical studies in Phases I to IV according to ICH/GCP and client-specific guidelines

• Investigator brochures

• Manuscripts for medical/scientific publications

• Posters and slide-kits for medical/scientific meetings

• Study protocols

• Clinical summaries (CTD Section 2.7) and clinical overviews (CTD Section 2.5)

• Periodic safety update reports (PSURs), PSUR summary bridging reports, and PSUR addendum reports

• Case narratives

• Risk management plans

• Company core data sheets

• Pre-IND submissions

• Clinical expert statements

• Competitor analyses

• Statistical analysis plans

• Mock tables for biometrical outputs

My experience covers all steps from planning to final quality control. I am familiar with electronic document publishing systems.

CONTINUING EDUCATION AND TRAINING COURSES

EMWA workshops: I am a member of the European Medical Writers Association (EMWA) and participating in EMWA’s professional development program. So far, I obtained credits in the following subjects:

• Essentials of editing and proof reading (2007)

• Writing a patient information leaflet for a clinical trial (2007)

• Data presentation I: tables and graphs (2004)

• Data presentation II: advanced data presentation (2004)

• Statistical thinking for medical writers (2004)

• Writing clinical study reports using ICH E3 (2004)

In addition, I attended the following non-credit workshops:

• The clinical study protocol: content and structure (2007)

• Subject narratives for clinical study reports (2007)

• The CTD clinical overview (2004)

• Drug safety for medical writers (2004)

Pharmacology of asthma and COPD: Course at the National Heart and Lung Institute, Faculty of Medicine, Imperial College London (2004)

Medical and scientific writing: Course by Dr Silvia Rogers, MEDIWRITE GMBH (2004)

Fundamentals of biometry: Course by Volker Steinijans, Senior Director Biometry and Clinical Data Management, ALTANA Pharma (2004)

Statistical planning and analysis of clinical Phase III trials in gastroenterology: Course by Dr Kai Grosch, Biometry Department, ALTANA Pharma (2003)

Windows 2000 and Microsoft Office 2000 (Word, Excel, PowerPoint): Courses by Kumatronik Datentechnik GmbH (2003)

Reference Manager 10: Course by Ortrud Höfling, Adept Scientific GmbH (2003)

Versioning of study reports: Course by Elvira Kiss, eDMS & Submission, ALTANA Pharma (2004)

Electronic clinical study reports: Course by Sibylle Teuchmann, eDMS & Submission, ALTANA Pharma (2003)

NovaManage – Complex Workflows: Course by Elvira Kiss, eDMS & Submission, ALTANA Pharma (2003)

RESEARCH EXPERIENCE

2000 - 2002

Postdoctoral fellow in the Laboratory of Immunopathology, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIAID/NIH), Bethesda, MD, USA.

• Studied the role of B cell co-receptors in Murine Acquired Immunodeficiency Syndrome (MAIDS)

• Studied the necessity of germinal centers for MAIDS development

• Was involved in studies on I B regulation in B cells

• Was participating in studies elucidating B cell lymphoma development

1999 - 2000

Postdoctoral research assistant in the Immunology department at the Institute of Virology and Immunoprophylaxis, Mittelhäusern, Switzerland.

• Studied the influence of monocytic cell activation on classical swine fever virus (CSFV) and African swine fever virus replication

• Was involved in general studies on phenotype and function of porcine monocytic cells

1996 - 1998

Doctoral student in the Immunology department at the Institute of Virology and Immunoprophylaxis, Mittelhäusern, Switzerland.

• Studied the effect of CSFV infection on porcine monocytes and macrophages

• Elucidated mechanisms of leucocyte loss and immunosuppression during classical swine fever

EDUCATION

1996 - 1998

Obtained my doctorate, thesis title "Immunopathogenesis of Classical Swine Fever: Role of Infected Monocytic Cells", in the Immunology department at the Institute of Virology and Immunoprophylaxis, Mittelhäusern, awarded through the University of Berne, Switzerland. Supervisor: Dr Arthur Summerfield

1990 - 1995

Obtained my DVM at the Justus-Liebig-University, Giessen, Germany

PUBLICATIONS

1. Doerre S, Mesires KP, Daley KM, McCarty T, Knoetig S, Corley RB. Reductions in I kappa B epsilon and changes in NF-kappa B activity during B lymphocyte differentiation. J Immunol. 2005;174(2):983-91

2. Knoetig SM, Torrey TA, Naghashfar Z, McCarty T, Morse HC, 3rd. CD19 signaling pathways play a major role for murine AIDS induction and progression. J Immunol. 2002;169(10):5607-14.

Link to full text article: http://www.jimmunol.org/content/169/10/5607.full.pdf

3. Knoetig SM, McCullough KC, Summerfield A. Lipopolysaccharide-induced impairment of classical swine fever virus infection in monocytic cells is sensitive to 2 aminopurine. Antiviral research. 2002;53(1):75-81

4. Hoyer KK, French SW, Turner DE, Nguyen MT, Renard M, Malone CS, Knoetig S, Qi CF, Su TT, Cheroutre H, Wall R, Rawlings DJ, Morse HC, 3rd, Teitell MA. Dysregulated TCL1 promotes multiple classes of mature B cell lymphoma. Proceedings of the National Academy of Sciences of the United States of America. 2002;99(22):14392-7

5. Knoetig S, Torrey TA, McCarty T, Morse HC, 3rd. From close encounters to fatal attraction: cellular interactions in MAIDS (Review). Recent Research Developments in Virology. 2001;3(1):81-90

6. Basta S, Knoetig S, Summerfield A, McCullough KC. Lipopolysaccharide and phorbol 12-myristate 13-acetate both impair monocyte differentiation, relating cellular function to virus susceptibility. Immunology. 2001;103(4):488-97

7. Summerfield A, McNeilly F, Walker I, Allan G, Knoetig SM, McCullough KC. Depletion of CD4 and CD8(high+) T-cells before the onset of viraemia during classical swine fever. Veterinary Immunology and Immunopathology. 2001;78(1):3-19

8. Summerfield A, Knoetig SM, Tschudin R, McCullough KC. Pathogenesis of granulocytopenia and bone marrow atrophy during classical swine fever involves apoptosis and necrosis of uninfected cells. Virology. 2000;272(1):50-60

9. Basta S, Carrasco CP, Knoetig SM, Rigden RC, Gerber H, Summerfield A, McCullough KC. Porcine alveolar macrophages: poor accessory or effective suppressor cells for T-lymphocytes. Veterinary Immunology and Immunopathology. 2000;77(3-4):177-90

10. Knoetig SM, Summerfield A, Spagnuolo-Weaver M, McCullough KC. Immunopathogenesis of classical swine fever: role of monocytic cells. Immunology. 1999;97(2):359-66. Link to full text article:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2326829/pdf/imm0097-0359.pdf

11. Basta S, Knoetig SM, Spagnuolo-Weaver M, Allan G, McCullough KC. Modulation of monocytic cell activity and virus susceptibility during differentiation into macrophages. J Immunol. 1999;162(7):3961-9

12. McCullough KC, Basta S, Knötig S, Gerber H, Schaffner R, Kim YB, Saalmuller A, Summerfield A. Intermediate stages in monocyte-macrophage differentiation modulate phenotype and susceptibility to virus infection. Immunology. 1999;98(2):203-12

13. Summerfield A, Knötig SM, McCullough KC. Lymphocyte apoptosis during classical swine fever: implication of activation-induced cell death. Journal of Virology. 1998;72(3):1853-61

PRESENTATIONS AT SCIENTIFIC MEETINGS

1. Knoetig SM, Torrey TA, Morse HC, 3rd. Restricted MAIDS development in OCA-B deficient mice. NIH Immunology Interest Group Retreat, Airlie, VA, USA, 2002

2. Knoetig SM, Torrey TA, McCarty T, Morse HC, 3rd. MAIDS is governed by signals through CD19, Vav and CD22. NIH Immunology Interest Group Retreat, Airlie, VA, USA, 2001

3. Knoetig SM, Summerfield A, McCullough KC. Proinflammatory factors from monocytic cells in classical swine fever. 4th Pestivirus Meeting, Giessen, Germany, 1999

4. Knoetig SM, McCullough KC, Basta S. Alveolar macrophages relate phenotypically and functionally to differentiating monocytes and monocyte-derived macrophages. Postgraduate Research Symposium on Molecular and Cellular Immunology, Sheffield, UK, 1999

5. Knoetig SM, Summerfield A, McCullough KC. Proinflammatory factors from monocytic cells in classical swine fever. 5th International Veterinary Immunology Symposium, Ludhiana, India, 1998

6. Summerfield A, Knoetig SM, McCullough KC. Apoptosis, necrosis and infection during classical swine fever virus-induced bonemarrow atrophie. 5th International Veterinary Immunology Symposium, Ludhiana, India, 1998

7. McCullough KC, Zingle K, Knoetig SM, Inumaru S, Summerfield A. In vitro infection of bone marrow haematopoietic cells by classical swine fever virus. 5th International Veterinary Immunology Symposium, Ludhiana, India, 1998

8. Knoetig SM, Summerfield A, McCullough KC. Infection with classical swine fever virus upregulates prostaglandin E2 production in porcine monocytes and macrophages. 13th European Immunology Meeting, Amsterdam, The Netherlands, 1997

9. Summerfield A, Knoetig SM, Schaffner R, Tschudin R, Arriens AM, Gerber H, McCullough KC. Programmed cell death involvement in acute leukopenia occurring in pigs infected with classical swine fever virus. 13th European Immunology Meeting, Amsterdam, The Netherlands, 1997

AWARDS OBTAINED

National Institutes of Health Fogarty International Fellowship (2000)

REFERENCES

Dr Martina Rauscher, Pharmacovigilance Scientist

Crucell Switzerland AG, Berne, Switzerland

e-mail: mgjsl7@r.postjobfree.com

Dr Maxwell Gough, Senior Medical Writer

Crucell Switzerland AG, Berne, Switzerland

e-mail: mgjsl7@r.postjobfree.com

Dr Claude Dumais-Huber, Clinical Development Manager

Nycomed GmbH, Konstanz, Germany

e-mail: mgjsl7@r.postjobfree.com

Ursula Aeberhard, Director Clinical Affairs International

Synthes GmbH, Solothurn, Switzerland

e-mail: mgjsl7@r.postjobfree.com

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