Clinical Trial Reg Affairs Principal Assistant

Job description

Work Schedule Standard Office Hours (40/wk) Environmental Conditions Office Job Description Join Us as a Principal Regulatory Affairs Assistant - Make an Impact at the Forefront of Innovation The Principal Regulatory Affairs Assistant provides advanced administrative and operational support to the Reg Affairs department. What You'll Do: • Provide administrative support to department and/or project teams. • Provide project specific services, documentation and coordination of projects and supports reporting of same to management, internal and external clients. • Support the Regulatory project team in coordinating and managing client deliverables to ensure compliance with SOPs. • Support the preparation of documentation and submissions related to them under guidance. • Electronically compile submissions. • Track documents and submissions in internal or sponsor systems as required. • File submission related documents as per internal or Sponsor SOP as applicable. • Liaise with internal clients to track and provide status updates of project deliverables Education & Experience Requirements: • High school / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Technical positions may require a certificate • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 years). • 3+ years’ experience in bid preparation and/or the development and fulfillment of contracts and RFP requirements is preferred In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills, Abilities: • Excellent organizational and planning skills to effectively manage shifting priorities • Strong understanding of contractal and proposal documents • 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. Working Conditions and Environment: • Work is performed in an office or clinical environment with exposure to electrical office equipment. • Occasional drives to site locations. Potential occasional travel required. Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. Apply today to help us deliver tomorrow’s breakthroughs.