An opportunity has arisen in our Regulatory, Medical & Quality Team which is responsible for ensuring that OGT’s products are safe, effective and fit for purpose, thus allowing them to be available globally and state of the art.
Reporting to our Medical Affairs Scientist, you will play an integral role supporting the Medical Affairs department with the provision of clinical evidence data (scientific validity, analytical performance and clinical performance) to support CytoCell® FISH probe technical files.
Your duties will include:
- Conducting literature reviews and writing literature reports to underpin the scientific validity and clinical performance of the CytoCell FISH probes
- Providing operational insights into clinical/scientific trial design, including clinical/scientific protocols, amendments, informed consent forms, study guides and case report forms
- Contributing to the documentation and infrastructure of the department by writing internal and external protocols and study plans
- Maintaining and administering internal files and providing clinical and administrative support to the Clinical Affairs team
- Providing support to the external study monitor, liaising and coordinating with external clinical sites to provide required clinical data
- Drafting study related documents from templates as directed
- Completion of clinical work required to support Intended Uses and Clinical Evidence Reports for assigned products
You will have:
- A BSc degree or equivalent in a science related subject, biology based or similar discipline
- Demonstrable experience in scientific writing and conducting systematic literature reviews. A background in molecular genetics / cytogenetics background with a focus on haematological malignancies and solid tumours (desirable)
- Continuously up to date clinical knowledge and the ability to communicate complex scientific ideas accurately
- The ability to use your scientific knowledge to solve problems
- Good organisation skills and be highly motivated
- An organised methodological approach to working, being able to manage your daily/weekly workload
- The ability to follow detailed processes
In return you will receive:
- Competitive salary
- Pension Scheme (10% non-contributory)
- Private Health Insurance
- 21 days holiday rising with service
- High Street Discount Scheme
Application is via CV & a one-page covering letter outlining your suitability for the role, salary expectations and confirming you have the right to work in the UK.
Closing date for applications is 24 September 2021.
No agencies please