The position as Regulatory/Clinical Administrator
We are looking for an experienced administrator who will be responsible for handling documentation in connection with clinical studies and regulatory applications. It goes without saying that you are structured and enjoy working in a supporting role. The work involves contacts both internally and externally with international CROs and other partners, which require good communication skills in English.
The position is full-time, until further notice and with access by appointment.Profile
We are looking for a person with at least a few years of experience working with documentation from clinical trials and documentation for regulatory use in an international environment. You should have very good knowledge of structured document management and be able to create effective solutions for sharing information on SharePoint.
Cantargia largely conducts its business in a virtual environment and it is therefore important that you are good at communicating and have a strong drive and ability to take own initiatives.Qualifications and experience
- Post-secondary education in science/medical sciences, or long experience of working with the development of pharmaceuticals or medical devices.
- Very good experience in structured electronic document management, preferably in a Sharepoint environment
- Experience in working with documentation for clinical trials, and especially Trial Master File (TMF)
- Experience of working with regulatory documentation
- Knowledge of Common Technical Document (CTD) for regulatory applications
- Experience of working with international contacts
- Good knowledge of Swedish and English, both spoken and written
- Very good knowledge in use of SharePoint for project information sharing
- Experience with Microsoft Office, preferably Microsoft Project
- Strong ability to structure information and ability to communicate clearly, both in verbally and in writing
- Appreciate working in a supportive role but at the same time being comfortable in taking your own initiative and working independently
- Be a team player with a good ability to work together
- Good at creating and maintaining constructive relationships with partners and colleagues
- Ability to quickly adapt to new conditions
- Have a positive attitude, commitment, and a drive of your own
In the role you use your experience of working with documentation under GxP as well as your knowledge of the content and structure of clinical and regulatory documentation. You also use your knowledge to create solutions on SharePoint for easy access to different types of documents for your project team. You will have the opportunity to make a difference for the team by taking responsibility for a very important part of the work in drug development in a phase where new clinical studies are starting up and the regulatory application work is intensified.
Since the company is small, you need to have a "can do" attitude and not be afraid to roll up your sleeves. While you are independent, you are also a proactive teamplayer. You will report to the company's VP Regulatory Affairs but also cooperate closely with primarily Clinical Operations and CMC.Main tasks and responsibilities
- Responsible for handling and electronic archiving of project-related scientific documentation in the areas of Clinical, CMC (Chemistry Manufacturing and Control) and Pre-Clinical
- Responsible for the handling and physical/electronic archiving of Trial Master Files (TMFs) in collaboration with CROs (Contract Research Organisations)
- Responsible for structuring documentation for regulatory use in accordance with the Common Technical Document (CTD)
- Responsible for templates for regulatory documents in accordance with CTD guidelines
- Design and be responsible for structures (initially on SharePoint) that allow easy access to archived documentation as well as to historical regulatory submissions
- Responsible for managing QA documentation such as Standard Operating Procedures (SOPs)
- Assist in the development of documentation and handle non-complex correspondence primarily within Clinical Operations and Regulatory Affairs.
The position is located at the office at Ideon in Lund.Opportunities
Cantargia aims to develop drugs that can become an important part of future cancer treatment as well as in autoimmune/inflammatory diseases. You will have the opportunity to work in an international environment in a small entrepreneurial pharmaceutical company, which is on the research front in immunonkology and whose research can make a big difference for patients with, among other things, non-small cell lung cancer and pancreatic cancer.ContactFor further information about the service, please contact Susanne Lagerlund,VP Regulatory Affairs,Cantargia AB (email@example.com))Application
You apply with your CV and cover letter through the application form. We encourage you to apply as soon as possible, though no later than 2020-10-31. All inquiries are treated confidentially. We are not able to accept applications via e-mail.