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Job #02735

About our client Our client is a world leading healthcare company that has developed a reputation for successfully bringing impacting products to market. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Clinical Research Scientist Manitoba Salary Highly competitive package, commensurate with experience Responsibilities 1) Develop clinical development plans and study protocols 2) Analyze clinical data and write clinical study reports 3) Provide scientific consultation and expertise throughout the clinical product development 4) Review scientific and medical literature that is relevant to the company's product therapeutic areas 5) Design clinical programs, concept sheets, and proposals to support clinical development 6) Develop investigator brochures and product labels, prescribing information 7) Interact with scientific and medical experts, opinion leaders, and study investigators regarding the development of clinical study protocols and programs 8) Design and write clinical study protocols to ensure scientific rationale and operational conduct 9) Interact with bio-statisticians to analyze and compile clinical data as well as write clinical study reports 10) Prepare clinical study reports, summaries, and supporting documents for regulatory submissions 11) Present clinical plans, results, and summaries to regulatory authorities including the FDA, Health Canada, and international authorities 12) Interact with Clinical Operations, Data Management, and Pharmacovigilance units during clinical study lifecycle 13) Interact with Regulatory Affairs and Business Development during product development and licensure 14) Provide scientific consultation and expertise throughout clinical product development Requirements 1) Advanced degree in Life Sciences (Ph. D. preferred) or medicine 2) Experience in the pharmaceutical industry a plus 3) Ability to demonstrate complex scientific and clinical issues in a regulated industry and to effectively present such information to management and regulatory authorities 4) Excellent written and oral communication skills