Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Essential Functions and Other Job Information:

Supports the preparation of documentation and submissions of North American IRB and REB submissionsCoordinates and manages client deliverables supporting regulatory compliance.Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects.Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines.Evaluates client needs in relationship to overall project timelines, quality and delivery.Engages with other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as neededProvides project specific services, documentation and coordination of projects and supports reporting of same to management, internal and external clients.

Education and Experience:

Excellent organizational and planning skills to effectively manage shifting priorities

Capable of working effectively on a team and/or independently with minimal supervisionExcellent electronic document production skillsExcellent proficiency in several computer applications including Microsoft Office softwareExceptional attention to detail and quality of documentationOutstanding interpersonal skills with the ability to interact with customersExcellent verbal and written communication skillsCapable of multitasking and working under pressureFirst-rate analytical, business and math skills

Bachelor’s degree in pharmacy or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 years). Prior experience with US or Canadian ethics committees that provides the knowledge, skills, and abilities to perform the job (comparable to 1+ years)