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Principal Regulatory Affairs Assistant
hace 1 mes
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 submissions.
- Coordinates 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 the final product and resolve/mitigate identified issues or barriers to delivery as needed.
- Provides project-specific services, documentation, and coordination of projects and supports reporting of the same to management, internal, and external clients.
Education and Experience:
- 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).
- Excellent organizational and planning skills to effectively manage shifting priorities.
- Capable of working effectively on a team and/or independently with minimal supervision.
- Excellent electronic document production skills.
- Excellent proficiency in several computer applications including Microsoft Office software.
- Exceptional attention to detail and quality of documentation.
- Outstanding interpersonal skills with the ability to interact with customers.
- Excellent verbal and written communication skills.
- Capable of multitasking and working under pressure.
- First-rate analytical, business, and math skills.
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