Parexel je globalna organizacija za klinične raziskave, ki biofarmacevtskim podjetjem pomaga pri razvoju novih zdravil. Njeno delo zajema klinične raziskave faz I–IV, upravljanje portfeljev in raziskav, regulativno strategijo, dostop do trga ter načrtovanje življenjskega cikla. Z več kot 21.000 strokovnjaki Parexel združuje klinično, regulativno in terapevtsko znanje z vpogledi v potrebe pacientov ter inovativnimi zasnovami raziskav. Podjetje podpira raziskave na področjih, kot so onkologija, nevroznanost in redke bolezni, s poudarkom na učinkovitejšem kliničnem razvoju, osredotočenem na paciente.
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.
Opis
- 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.
Zahteve
- 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.
Ugodnosti
- 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.