Karen Maigetter

 

Professional Activities

  • Clinical Research Scientist/Regulatory Liaison, Department for Pharmaceutical Medicine, STI
  • Examining the need for consultations & collaborations in the area of drug regulatory affairs in emerging markets & resource limited countries in the international market
  • Selecting relevant projects for STI-DPM & writing letters of intent & project applications
  • Conducting consultations in selected projects & procured contracts
  • Building the competence of drug regulatory affairs with special emphasis on resource limited countries including the training/coaching of internal staff
  • Interacting with external project sponsors, national & regional drug regulatory authorities, specialized units of international organizations & clinical trial sponsors to support the vision of STI as a collaborative partner

Higher Education & Qualifications

  • 2005 London Business School: Insights for Pharma, London, UK
  • 1992 International Executive Leadership Program for Women; Bruges, Belgium
  • 1988 BOC/Anaquest Management Training Program; Madison, Wisconsin, USA
  • 1982 Seton Hall University, South Orange, New Jersey, USA; MSc. Biology/Business Administration
  • 1969 The Ohio State University, Columbus, Ohio, USA; BSc. Microbiology
  • 1966 The National University of Mexico & The University of the Americas; Exchange Student

Work Experience

  • 2009-present: Clinical Research Scientist/Regulatory Liaison, Department for Pharmaceutical Medicine, Pharmaceutical Medicine Unit, STI
  • 1990-2009: F. Hoffmann-La Roche, Ltd., Basel, Switzerland, International Regulatory Affairs: Regulatory Advisor, 2009; Head of Regional Management, 2003-08; Head of Product & Countries Support, 1999-03; Group Leader, 1998-99; Senior Manager, 1990-97
  • 1984-1990: Anaquest, A Division of British Oxygen Corporation (BOC) [currently The Linde Group], Murray Hill, New Jersey, USA, Drug Regulatory Affairs: Associate Director, 1989-90; DRA Manager, 1988-90; DRA Specialist, 1986-99; DRA Senior Associate, 1984-86
  • 1976-1984: Newark Beth Israel Medical Center, Newark, New Jersey, USA, Pediatrics & Infectious Diseases: Research Associate
  • 1972-1975: Mt. Sinai Hospital Medical Center, Chicago, Illinois, USA Department of Oncology: Research Technologist
  • 1969-1971: Riverside Methodist Hospital, Columbus, Ohio, USA: Clinical Bacteriologist