Regulatory publishing consultant supporting eCTD systems and regulatory technology for Parexel’s global clinical research services. Troubleshooting, validating, and advising clients on submission platforms.
About the role
- Regulatory publishing consultant supporting eCTD and regulatory systems for Parexel’s global clinical research solutions. Troubleshooting platforms, validating technology, and advising clients on regulatory submissions.
Responsibilities
- Provide technical support for regulatory publishing and submission management systems
- Troubleshoot issues related to eCTD publishing tools, document management systems, PDF creation, Microsoft Office applications, and desktop environments
- Configure, install, test, validate, and maintain regulatory technology solutions
- Support system validation activities, execute test scripts, and document results
- Maintain compliance with regulatory submission standards, publishing guidelines, and industry best practices
- Manage multiple priorities while ensuring high-quality deliverables and service levels
- Partner with clients, regulatory teams, and software vendors to resolve technical challenges and deliver effective solutions
- Act as a trusted advisor on publishing technologies and regulatory systems
- Support project teams by sharing expertise and mentoring less experienced team members
- Participate in client meetings and provide recommendations to improve efficiency and system utilization
- Build strong relationships with internal and external stakeholders while ensuring client satisfaction
Requirements
- 3+ years of experience in Regulatory Operations, Regulatory Publishing, eCTD Submission Management, Regulatory Technology Support, or Regulatory Information Management (RIM)
- Experience supporting or using Veeva Vault RIM, Documentum, EXTEDO, Lorenz, Calyx RIM, or similar regulatory publishing/document management systems
- Strong understanding of eCTD submissions, regulatory publishing processes, global regulatory submission standards, and submission lifecycle management
- Experience performing system troubleshooting, software testing, validation activities, and user support
- Advanced proficiency with Microsoft Office Suite, Adobe Acrobat, and Windows operating systems
- Fluent English communication skills, both written and verbal
- Bachelor's degree in Life Sciences, Technology, Computer Science, Pharmacy, Regulatory Affairs, or a related field
- Experience writing and executing validation protocols and test scripts preferred
- Experience working within a CRO, pharmaceutical, biotechnology, or regulatory technology environment preferred
- Prior client-facing or consulting experience preferred
- Experience mentoring team members or acting as a subject matter expert 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
- Flexible work environment
- Growth opportunities
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