127 days ago on career.ibsa.ch


IBSA Institut Biochimique SA

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 Please refer to JobSuchmaschine in your application


Main responsabilities and tasks
  • Design, planning, coordination and implementation of preclinical and clinical studies (phase I-IV), both directly and through Contract Research Organisations (CROs)
  • Contribution in the development of project strategy, including budget definition and monitoring, and clinical development plans
  • Execution of study related regulatory procedures (i.e. notification/submission to Regulatory Authorities, including electronic applications, and submission to Ethical Committees) directly or through CROs
  • Identification and quality evaluation of research centres and CROs
  • Interface and collaboration with Regulatory Affairs Dept., Clinical Data Management and Statistics Dept., pharmaceutical Development Dept., Drug Safety Unit, Clinical Quality Assurance Unit, Marketing Dept
  • Planning and writing of study protocols, independently or in cooperation with opinion leaders
  • Writing of study related documentation (i.e. Investigator’s Brochure, CRF, patient's information sheet and consent form).
  • Evaluation of pre-clinical and clinical data and contribution in writing clinical study reports and scientific publications
  • Writing of clinical documentation as required for regulatory authorities submission (eCTD)
  • Participation to national and international meetings with affilated companies or distributors
  • Participation to scientific advice meetings and preparation of the relevant scientific documentation.
  • Development of documentation and presentations for scientific meetings at Regulatory Agencies
  • Organisation of meetings and international congresses: contacts with speakers, abstracts,  preparation and revision of presentation in collaboration with the congress manager and Marketing Dept.
Your profile
  • Academic degree in Pharmacy, Biology or Pharmaceutical Chemistry
  • Good knowledge of English written and spoken
  • Previous work experience in the area of competence
  • We are looking for an open minded analytical thinking person, which is capable to resolve complex matters, team work oriented and highly motivated

IBSA Institut Biochimique SA in Pambio-Noranco, Ticino, Switzerland

Scientific Research and Development

Laut Paragraph n°1 L.903/77 und n°4 L.125/91 ist diese Anzeige sowohl an männliche als auch weibliche Kandidaten gerichtet.