Senior Compliance Specialist
Jabil
Regulatory Publishing Specialist, Advanced Word Formatting
Thermo Fisher Scientific
full-time
Posted on:
Location: 🇲🇽 Mexico
Visit company websiteJob 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.)
