About the role
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.
Originally posted on Himalayas