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Principal Regulatory Affairs Assistant

AT Thermo Fisher Scientific
Thermo Fisher Scientific

Principal Regulatory Affairs Assistant

Remote

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.

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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)

Job ID: ThermoFisher-R-01286108_1004-1
Employment Type: Full Time

Perks and Benefits

  • Health and Wellness

    • Health Insurance
    • Dental Insurance
    • Vision Insurance
    • Life Insurance
    • Short-Term Disability
    • Long-Term Disability
    • FSA
    • HSA
    • HSA With Employer Contribution
    • Mental Health Benefits
    • Fitness Subsidies
  • Parental Benefits

    • Adoption Leave
    • Birth Parent or Maternity Leave
    • Non-Birth Parent or Paternity Leave
    • Fertility Benefits
    • Adoption Assistance Program
    • Family Support Resources
  • Work Flexibility

    • Flexible Work Hours
    • Hybrid Work Opportunities
    • Remote Work Opportunities
  • Office Life and Perks

    • Commuter Benefits Program
    • On-Site Cafeteria
  • Vacation and Time Off

    • Paid Vacation
    • Paid Holidays
    • Volunteer Time Off
  • Financial and Retirement

    • 401(K) With Company Matching
    • Stock Purchase Program
    • Financial Counseling
    • Performance Bonus
  • Professional Development

    • Tuition Reimbursement
    • Access to Online Courses
    • Internship Program
    • Mentor Program
  • Diversity and Inclusion

    • Employee Resource Groups (ERG)
    • Diversity, Equity, and Inclusion Program