Technical Consultant – Regulatory Affairs Operation
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Job Description
Technical Consultant supporting Parexel’s regulatory publishing systems and validation tools remotely from Mexico. Advising clients and internal teams on compliant technology solutions.
Responsibilities:
- Assist team with ongoing systems management activities and manage customer expectations around software functionality, stability, and maintenance
- Provide advanced troubleshooting for paper and electronic publishing systems, PDF, Word, and desktop applications
- Perform computer software setup, installation, configuration, testing, and troubleshooting
- Document work activities including system validation, troubleshooting activities, and internal work requests
- Execute publishing system validation tests following established documentation and best practices
- Maintain familiarity with current and future global regulatory submission standards and departmental best practices
- Prioritize workload and project activities to achieve project scope and objectives
- Work with clients, internal partners, and software vendors to develop and deliver solutions
- Provide guidance to project team members and mentor junior staff
- Serve as subject matter expert on important projects and leverage previous project knowledge to improve efficiency
- Plan and deliver services that result in client satisfaction and build relationships for additional business opportunities
- Facilitate resolution of technology-related problems with project teams and clients
- Interact professionally at multiple organizational levels, including senior management within client organizations
Requirements:
- Strong understanding of global regulatory submission formats, industry standards, guidelines, and publishing best practices
- Proficiency in Microsoft Windows desktop and server environments
- Advanced proficiency with Microsoft Office products and Adobe Acrobat
- Hands-on experience with document management systems (e.g., Documentum, EXTEDO, Lorenz, Calyx RIM, Veeva Vault)
- Fluent in English
- Advanced troubleshooting techniques for publishing systems and desktop tools
- Experience writing and executing validation and quality test scripts
- Excellent verbal and written communication skills
- Ability to manage multiple priorities with strong attention to detail
- Client-focused approach and ability to work effectively in a matrix environment
- Flexibility, teamwork orientation, and willingness to learn new technologies
- 3-5 years of experience in Regulatory Operations, Publishing, or Regulatory Technology support roles (preferred qualifications)
- Bachelor's degree in Technology, Life Sciences, or a related field (preferred)
- Experience with software validation and quality assurance activities (preferred)
- Demonstrated consulting skills and ability to mentor junior team members (preferred)
Benefits:
- Opportunity to work with cutting-edge regulatory technology and publishing systems
- Exposure to global regulatory standards and best practices
- Collaborative, matrix-based environment with opportunities for mentoring and professional development
- Direct client engagement and the ability to drive meaningful business solutions
- Competitive compensation and comprehensive benefits package
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