Technical Consultant – Regulatory Affairs Operation

Job not on LinkedIn

🔥 12 hours ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• 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