Principal Regulatory Affairs Assistant

Detalhes da Vaga

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Office

**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**:
Excellent organizational and planning skills to effectively manage shifting priorities
- Capable of working effectively on a team and/or independently with mínimal supervision
- Excellent electronic document production skills
- 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

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)


Salário Nominal: A acordar

Fonte: Whatjobs_Ppc

Função de trabalho:

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