Job Information
ThermoFisher Scientific Principal Regulatory Affairs Assistant in Remote, Peru
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:
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
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)
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.