Parexel este o organizație globală de cercetare clinică ce deservește companii biofarmaceutice pe parcursul dezvoltării de medicamente noi. Activitatea sa acoperă studii clinice de fază I–IV, gestionarea portofoliilor și a studiilor, strategia de reglementare, accesul la piață și planificarea ciclului de viață. Cu peste 21.000 de profesioniști, Parexel îmbină expertiza clinică, de reglementare și terapeutică cu perspectivele pacienților și designuri inovatoare ale studiilor. Compania sprijină cercetarea în domenii precum oncologia, neuroștiințele și bolile rare, punând accent pe eficientizarea dezvoltării clinice și pe orientarea acesteia către pacienți.
Regulatory Publishing Technical Consultant, Regulatory Systems
Support regulatory publishing platforms and eCTD systems for Parexel’s global clinical research services. Troubleshoot, validate, and advise clients on submission technology.
Descriere
- Support regulatory publishing and submission management platforms.
- Resolve issues across eCTD publishing tools, document management systems, PDF creation, Microsoft Office, and desktop environments.
- Set up, test, validate, and maintain regulatory technology solutions.
- Assist with system validation, run test scripts, and record outcomes.
- Follow regulatory submission standards, publishing guidance, and industry practices.
- Balance competing priorities while meeting quality and service expectations.
- Work with clients, regulatory teams, and software vendors to address technical issues.
- Advise clients on publishing tools and regulatory systems.
- Share expertise with project teams and mentor less experienced colleagues.
- Join client discussions and suggest ways to improve efficiency and system use.
- Build internal and external partnerships and support client satisfaction.
Cerințe
- At least three years of experience in Regulatory Operations, Regulatory Publishing, eCTD Submission Management, Regulatory Technology Support, or Regulatory Information Management (RIM).
- Experience with Veeva Vault RIM, Documentum, EXTEDO, Lorenz, Calyx RIM, or comparable regulatory publishing or document management systems.
- Solid knowledge of eCTD submissions, publishing workflows, 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.
- Preferred: experience drafting and executing validation protocols and test scripts.
- Preferred: experience in a CRO, pharmaceutical, biotechnology, or regulatory technology setting.
- Preferred: client-facing or consulting experience.
- Preferred: experience mentoring colleagues or serving as a subject matter expert.
Beneficii
- Work with advanced regulatory technology and publishing platforms.
- Gain exposure to global regulatory standards and practices.
- Join a collaborative, cross-functional environment with mentoring and professional development opportunities.
- Engage directly with clients and help deliver practical business solutions.
- Competitive pay and a comprehensive benefits package.
- Enjoy flexibility, opportunities to grow, and room to do your best work.