Thermo Fisher Scientific

Regulatory Publishing Specialist, Advanced Word Formatting

Thermo Fisher Scientific

full-time

Posted on:

Origin:  • 🇲🇽 Mexico

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Job Level

JuniorMid-Level

Tech Stack

Unity

About the role

  • Coordinates and manages client electronic submission deliverables supporting regulatory compliance
  • Prepares electronic document outputs that meet requirements for regulatory publishing and agency/sponsor software
  • Ensures final electronic deliverables meet current regulatory electronic document requirements and guidance
  • Serves in a quality review role; reviews documents created within or outside the company to ensure quality
  • Assists with developing and implementing project-specific processes and may act as company liaison for electronic submissions
  • Evaluates publishing needs relative to project timelines, quality and delivery and engages team members as necessary
  • Acts independently within project teams to evaluate and deliver publishing tasks and resolve issues
  • Ensures successful regulatory review outcomes for product milestones

Requirements

  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification
  • Previous experience comparable to 2+ years
  • In some cases combination of education, training and/or directly related experience accepted as equivalent
  • Working knowledge of regulatory requirements and guidances for document management and electronic submissions
  • Strong knowledge of Microsoft Word, MS Excel, Adobe Acrobat
  • Knowledge of electronic document management systems and document publishing tools (i.e. ISIToolbox)
  • Experience with publishing systems (i.e. docuBridge, Veeva Submission Publishing)
  • Experience with eCTD validation and viewing tools
  • Strong knowledge of electronic templates and skilled in formatting and troubleshooting templates
  • Ability to manage several complex projects in parallel and adapt to changing priorities
  • Ability to exercise independent judgment using defined procedures and practices
  • Ability to independently assess sponsor needs and work with project team members
  • Ability to independently learn new technologies
  • Strong organizational, interpersonal, analytical, and problem-solving skills
  • Good working knowledge of medical terminology, statistical concepts, and regulatory guidelines (FDA and other international agencies)
  • Strong editorial/proofreading skills; detail-oriented and methodical
  • Ability to create and follow timelines, conduct long-range planning, and multi-task
  • Ability to communicate information and ideas clearly and listen effectively
  • Ability to perform physical requirements (upright/stationary 6-8 hours, repetitive hand movement, light lifting up to 15-20 lbs.)