Regulatory Operations Technical Consultant (eCTD Publishing & Regulatory Systems)

Job description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Technical Consultant Regulatory Operations | Parexel Work Schedule: 11:00 AM - 8:00 PM (Mexico Time) - MANDATORY Role Overview We are seeking a Technical Consultant to join our Regulatory Operations team at Parexel. In this role, you will provide comprehensive support for our electronic publishing systems, validation tools, repositories, and related components that enable regulatory operations. You will work with both external customers and internal employees, providing expert guidance on tools and systems used for regulatory outsourcing activities. This position offers an excellent opportunity to leverage your technical expertise and consulting skills in a dynamic, client-focused environment. Key Responsibilities System Management & Support 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 Consulting & Client Engagement 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 Mandatory Requirements Technical Knowledge & Expertise 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 Professional Competencies 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 Preferred Qualifications 3-5 years of experience in Regulatory Operations, Publishing, or Regulatory Technology support roles Bachelor's degree in Technology, Life Sciences, or a related field Experience with software validation and quality assurance activities Demonstrated consulting skills and ability to mentor junior team members What We Offer 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 Parexel is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.