Careers

Careers




Open position
R&D Scientific Affairs Specialist


Description of activities and responsibilities:
 
  • Monitoring according to ICH-GCP, local regulations and laws, of clinical studies (Phase I - IV) on drugs and medical devices.
  • Support in the identification and quality evaluation of research centres and CROs, in agreement with the R&D SA management and department Head.
  • Design, planning, coordination and management of preclinical and clinical studies (Phase I - IV) on drugs and medical devices, both directly and through Contract Research Organisations (CROs), worldwide.
  • Execution of study related regulatory procedures (i.e., notification/submission to Regulatory Authorities, including electronic applications, and submission to Ethical Committees) and drug supply procedures.
  • Preparation of Investigational Medicinal Product/Device requisition/packaging & labelling request, coordination of IMP/IMD management (supply and return) activities and process.
  • Organization and Conduction of Investigators’ Meetings.
  • 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.
  • Medical writing of clinical documents as required for regulatory authorities submission
  • Participation to national and international meetings.
  • Contribution in the development of project strategy, including budget definition, and clinical development plans.
  • Contribution in the participation to scientific advice meetings and preparation of the relevant scientific documentation.
  • Contribution in the development of documentation and presentations for scientific meetings at Regulatory Agencies.
  • Contribution in the editing of clinical regulatory documents.
  • Contribution in the organisation (contacts with speakers, abstracts and presentation preparation and revision) of scientific symposia at meetings and international congresses.

Requirements:
  • Master's degree in scientific field, a PhD degree will be a plus;
  • At least 2 years of experience in managing or participating in the management of clinical trials, possible experience in pre-clinical research with drugs and/or medical devices;
  • Excellent knowledge of regulations and guidelines for clinical trials with drugs and/or medical devices;
  • Experience in areas related to scientific communication, e.g. publications, relations to local and international scientific congresses and events, medical writing in general;
  • Excellent knowledge of written and spoken English.

Work location
IBSA Institut Biochimique SA,  Lugano, Ticino, Svizzera.


 



Business unit
Scientific Research and Development
Sedi
Svizzera/Lugano



Ai sensi degli articoli n°1 L.903/77 e n°4 L.125/91 questo annuncio e diretto a candidati dell'uno e dell'altro sesso.