Parexel एक वैश्विक क्लिनिकल रिसर्च संगठन है, जो नई दवाओं के विकास के दौरान बायोफार्मास्यूटिकल कंपनियों को सेवाएँ प्रदान करता है। इसका कार्य चरण I–IV क्लिनिकल परीक्षणों, पोर्टफोलियो और परीक्षण प्रबंधन, नियामक रणनीति, बाज़ार तक पहुँच तथा जीवनचक्र योजना तक फैला हुआ है। 21,000 से अधिक पेशेवरों के साथ, Parexel क्लिनिकल, नियामक और उपचार-विज्ञान संबंधी विशेषज्ञता को मरीजों की अंतर्दृष्टि और नवीन परीक्षण डिज़ाइनों के साथ जोड़ता है। कंपनी ऑन्कोलॉजी, न्यूरोसाइंस और दुर्लभ रोगों सहित विभिन्न क्षेत्रों में अनुसंधान का समर्थन करती है और क्लिनिकल विकास को अधिक कुशल तथा मरीज-केंद्रित बनाने पर ध्यान देती है।
Regulatory Publishing Technical Consultant
Support Parexel’s regulatory publishing systems and eCTD submissions for global clinical research. Troubleshoot platforms, validate technology, and advise clients on effective regulatory workflows.
विवरण
- Provide technical assistance for regulatory publishing and submission management systems.
- Resolve issues involving eCTD publishing tools, document management systems, PDF creation, Microsoft Office, and desktop environments.
- Configure, install, test, validate, and maintain regulatory technology.
- Assist with system validation, run test scripts, and record results.
- Follow regulatory submission standards, publishing guidelines, and industry practices.
- Balance competing priorities while delivering high-quality work and service.
- Work with clients, regulatory teams, and software vendors to address technical issues and implement solutions.
- Advise clients on publishing technologies and regulatory systems.
- Share expertise with project teams and mentor less experienced colleagues.
- Join client meetings and recommend ways to improve efficiency and system use.
- Build productive relationships with internal and external stakeholders and support client satisfaction.
आवश्यकताएँ
- At least three 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 comparable regulatory publishing or document management systems.
- Solid knowledge of eCTD submissions, regulatory publishing processes, global submission standards, and submission lifecycle management.
- Experience troubleshooting systems, testing software, conducting validation activities, and supporting users.
- Advanced skills with Microsoft Office, Adobe Acrobat, and Windows operating systems.
- Fluent written and spoken English.
- Bachelor’s degree in life sciences, technology, computer science, pharmacy, regulatory affairs, or a related discipline.
- Experience authoring and executing validation protocols and test scripts is preferred.
- Experience in a CRO, pharmaceutical, biotechnology, or regulatory technology setting is preferred.
- Client-facing or consulting experience is preferred.
- Experience mentoring colleagues or serving as a subject matter expert is preferred.
लाभ
- Work with current regulatory technology and publishing systems.
- Gain exposure to global regulatory standards and practices.
- Join a collaborative, matrix-based team with mentoring and professional development opportunities.
- Engage directly with clients and contribute to business solutions.
- Competitive compensation and a comprehensive benefits package.
- Flexible work environment.
- Opportunities for career growth.