General Submission
Red Cell PartnersFull Time
Entry Level & New Grad, Mid-level (3 to 4 years), Senior (5 to 8 years), Expert & Leadership (9+ years)
Candidates should possess a Bachelor's degree or equivalent, with at least 2 years of relevant experience. A strong understanding of regulatory requirements and guidances for document management and electronic submissions is necessary. Proficiency in Microsoft Word, Excel, Adobe Acrobat, electronic document management systems, document publishing tools like ISIToolbox, and publishing systems such as docuBridge or Veeva Submission Publishing is required. Familiarity with eCTD validation and viewing tools, along with strong knowledge of electronic templates and formatting/troubleshooting skills, is essential. The role demands excellent organizational, interpersonal, and analytical abilities, along with the capacity to manage multiple complex projects and adapt to changing priorities.
The Regulatory Publishing Specialist is responsible for the preparation of client electronic submission deliverables and dossiers that meet current regulatory and technical requirements, ensuring successful regulatory review outcomes. This role involves coordinating and managing electronic submission deliverables, assisting in the preparation of electronic document outputs for regulatory publishing, and ensuring final deliverables adhere to current regulatory electronic document requirements and guidance. The specialist will also assist in developing and implementing project-specific processes, act as a liaison for electronic submissions, and evaluate publishing needs in relation to project timelines, quality, and delivery. They will engage project team members and functional units to resolve issues and deliver final products, working independently on publishing tasks and assessing sponsor needs to produce compliant deliverables.
Provides life sciences products and services
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.