Principal Regulatory Affairs Assistant

Detalles de la oferta

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 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 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). Skills: 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. #J-18808-Ljbffr


Salario Nominal: A convenir

Fuente: Whatjobs_Ppc

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