•Review of scientific and medical literature relevant to Cangene product therapeutic areas •Design of clinical programs, concept sheets and proposals to support clinical development •Development and writing of investigator brochures and product labels/prescribing information •Search, identification, engagement and interaction with scientific and medical experts and opinion leaders and study investigators regarding the development of clinical study protocols and programs. •Design and writing of clinical study protocols and investigator brochures to ensure scientific rationale and operational conduct •Interaction with biostatisticians to analyze and compile clinical data and write clinical study reports •Preparation of clinical study reports, annual IND submissions, summaries and supporting documents for regulatory submissions. •Presentation of clinical plans, results and summaries to regulatory authorities including the FDA, Health Canada and internationally •Interaction with Clinical Operations, Data Management and Pharmacovigilance (PV) units during clinical study lifecycle •Interaction with Regulatory Affairs and Business Development during product development and licensure •Search, identification and recruitment of CROs and sending request for proposals •Occasional review of PV Individual Case Safety Reports •Communication with French Regulatory Agency (AFSSAPS) (in French) •Occasional responds to various technical/medical demands (in French)

•Identification of target antigens for autoantibodies in rheumatoid arthritis, ostheoarthritis and psoriasis for possible diagnostic and potential therapeutic procedures’ development. Monoclonal antibody production, Western blotting, immunoprecipitation, ELISA, 2D-PAGE, immunohistochemistry, immunofluorescent microscopy, affinity chromatography, mammal cell culture/tissue etc, in-membrane, in-gel protein digestion, HPLC, MS etc. •Documentation and handling of clinical samples according to PHIA •Research project set-up and development. •Literature review and results’ reporting/publishing. •Participation in clinical and scientific workshops, seminars and conferences. •Practical teaching of 2D-PAGE and other methodology

Immunology/Hematology, PhD of Biomedical Sciences

General Medicine, MD

Life Science Assotiation of Manitoba, n/a