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.
- 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.
IBSA Institut Biochimique SA, Lugano, Ticino, Svizzera.