- Closing date 8 May 2021
- Type Full-time
- Duration Permanent
Oxford Gene Technology (OGT) provides world class genetic research solutions to leading clinical and academic research institutions. We are a rapidly growing company with state-of-the-art facilities and over 100 employees based at our Cytocell® office in Cambridge and our head office in Oxford. With customers in over 60 countries worldwide and ambitious expansion plans, we have a strong reputation and increasing share in the large and growing genomic medicine market.
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 Director of Medical Affairs, you will provide input and management from a Medical Affairs perspective on a range of organisation wide (including Sysmex) projects.
Your duties will include:
- Providing project input and management for Medical Affairs and other departments across the organisation, e.g. in-house V&V studies, in-house R&D studies, probe development
- Acting as the subject matter expert on CytoCell® projects
- Planning, setting goals and objectives, defining roles and producing schedules and timelines for tasks in accordance with project requirements
- Managing projects including coordination of the project team, ensuring that all projects are delivered on time, within scope and within budget, monitoring and controlling activities to track project progress and closing projects
- Performing risk management to minimise risks, including carrying out risk assessments and tracking project performance
- Ensuring studies are carried out to the study protocol, SOPs and GCP regulations and study specific manuals and procedures, by document review and/or planned site monitoring
- Tracking and reporting on progress to timelines of studies for which personally accountable, reviewing key quality metrics such as eligibility and primary endpoint data and determine appropriate action in conjunction with the Director of Medical Affairs
- Full participation in the identification, selection and monitoring performance of investigational sites for scientific studies, developing and maintaining strong working relationships with investigators and study staff
- Creating scientific/project content for in-house and training presentations
- Create and maintain scientific study master files and archive as appropriate
- Be qualified to a minimum of BSc or equivalent in biological related discipline such as Biological Sciences
- Have broad knowledge of current GCP/IVD regulations for devices and diagnostics
- Have demonstrable experience in Project Management and design control for IVD, medical device development within an IVD, medical device, clinical or related field
- Have good attention to detail with an organised methodical approach to working
- Be excellent at time management with the ability to priorities tasks
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 8 May 2021.
No agencies please