Parexel yra pasaulinė klinikinių tyrimų organizacija, teikianti paslaugas biofarmacijos įmonėms viso naujų vaistų kūrimo proceso metu. Jos veikla apima I–IV fazės klinikinius tyrimus, portfelio ir tyrimų valdymą, reguliavimo strategiją, patekimo į rinką klausimus ir vaistų gyvavimo ciklo planavimą. Daugiau nei 21 000 specialistų turinti Parexel derina klinikinę, reguliavimo ir terapinių sričių kompetenciją su pacientų įžvalgomis bei novatoriškais tyrimų modeliais. Įmonė remia mokslinius tyrimus onkologijos, neuromokslų ir retųjų ligų srityse, siekdama, kad klinikinė plėtra būtų efektyvesnė ir labiau orientuota į pacientus.
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.
Aprašymas
- 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.
Reikalavimai
- 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.
Privalumai
- 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.