Cerner Enviza an Oracle company- Senior Regulatory Analyst (F/M) CDI
Cerner Enviza an Oracle Company is a leading global healthcare consulting firm and trusted advisor to many of the world’s top pharmaceutical, biotech, and medical device & diagnostic companies. By supporting the work of Cerner Enviza an Oracle Company, you will work with world-class healthcare companies, helping them improve global access to medicines by connecting science and research. Cerner Enviza is passionate about our people, our business, and our clients and is proud to foster a culture that contributes to the health and well-being of humankind. Leading through innovation, we consistently challenge ourselves to discover and embrace new and creative ways to deliver exceptional insight for clients.
Together we leverage a diverse network of providers and data, expert research capabilities and actionable analytics to bring remarkable clarity to life sciences’ most important decisions.
With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to work in Life Sciences and, with Cerner Enviza immersed in all of these, there has never been a better time to join us and make a difference to our clients and the lives of patients.
Thanks to our Business growth Cerner Enviza is looking for a Senior Regulatory Analyst for the Real-World Evidence (RWE) Domain with a strong focus on NIS (Non-Interventional- Studies) activities.
You will join a team of experts in regulatory and ethics submissions of clinical research studies. You will focus on facilitating the start of research projects while taking a step further in your professional career.
You will be surrounded by passionate colleagues in an open and engaging environment.
- Prepare clinical research submission dossiers for Competent Authorities and Ethics Committees
- Review translations of essential documents subject to clinical research submission
- Track the application process, amendments until study close-out
- Communicate with Competent Authorities, Ethics Committees, project teams and vendors on regulatory-related matters
- Maintain the regulatory project documentation flow
- Manage safety reporting to authorities, when applicable
- Support the regulatory and study team on feasibility assessment and business development requests
- Assist in regulatory surveillance and regulatory development tools
- Bachelor degree or an equivalent combination of education, training, and experience;
- At least 4 year of prior experience with clinical research submissions, including informed consent documents;
- Knowledge of clinical research regulations and guidelines that govern clinical research is preferred;
- Fluency in English and French (C2)
- Good knowledge of GDPR
- Advanced knowledge of Microsoft Word, Excel, and PowerPoint;
- Excellent planning, organizational and problem-solving skills;
- Excellent communication skills – able to distill issues, manage client expectations and act as a trusted advisor in a timely manner;
- Ability to work effectively in a team in a fast-paced and dynamic environment;