Regulatory Publishing Technical Consultant – Regulatory Systems

🔥 1 minute ago

🇨🇦 Canada – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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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

• 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