Short Biography for Rosemary Bischoff
ClinWrite Berlin

In all, I have over 30 years experience as a medical writer, clinical project leader and line manager in the pharmaceutical industry, covering the full range of Phase I and clinical trials-related and submission-related activities, as well as having written review articles, original articles, conference proceedings, posters and training materials. My major areas of experience are: phase I, psychiatry, neurology, gynecology, dermatology, oncology and endocrinology. I also have a certain amount of experience in veterinary medicine research. In addition, I have approximately 14 years of experience in training (training new staff in my previous role as line manager, workshop leader for the European Medical Writers Association and customized contract training). For many years I was a member of the European Medical Writers Association's (EMWA) Educational Committee. I have self-authored scientific publications (see below) in both German and English during the period spent as a clinical project leader: 6 original articles, 6 Review articles, 5 posters, 1 book (editor)
Current position
ClinWrite, Berlin, Germany (own business) 1998-present

Medical writer:

  1. All forms of regulatory documents to ICH standards including investigators brochures, study protocols, study reports, submission documents (clinical summaries and clinical overviews for CTDs) and PSURs.
  2.  publication manuscripts, posters  and training materials
  3. translations and editing for non-native speakers; 2-way (forward and backward) translation of clinical rating instruments for use in multicenter trials (German and English),


EMWA workshop leader for the training topic Clinical Study Design: basic and advanced courses and I lead a master class in Editing Documents Originating From Non-Native Speakers of English.

Customized training for groups and individual, coaching in scientific writing for non-native speakers utilizing documents authored by the participants.

Previous positions
Head of Clinical Development Support, Therapeutics Schering AG, Berlin, Germany 1994-1998
Main activities:

Line Manager for all medical writers, CRAs and archive function. The position also included responsibility for outsourcing.

Clinical project leader Schering AG, Berlin, Germany 1978-1994

Main activities:

Responsible for planning and leading the European Phase III and overseeing the reports and summary documents for the licensing application for an anxiolytic, in cooperation with a US American development partner.

Plan, conduct and report phase II and III for an antidepressant.

Plan, conduct and report Phase II and III and write submission dossiers for an oral, sublingual and iv formulated benzodiazepine in the indications insomnia and premed. for surgical procedures

Scientist, CNS Phase I unit Schering AG, Berlin, Germany 1974-1978
Main activities:

Responsible for planning and conducting phase I studies in CNS and authoring review articles.

BA Hons in Social Science (psychology specialty) York University, UK 1971-1974
MS in applied psychology, George Peabody College, Berlin subsidiary 1976-1977
Admission to the Freie Universität, Berlin as part-time doctoral student (dissertation not completed) 1979
Language skills
English (mother tongue)
German (fluent)

Professional association European Medical Writers Association