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OGT is a leading global provider of clinical and diagnostic genomic solutions. We believe in creating products and partnerships that enable clinicians to deliver personalised healthcare to patients and that empower clinical researchers to develop the next generation of precision medicines.
This position is a fixed-term contract, ending in December 2028
An opportunity has arisen in our Medical Affairs team for a Medical Affairs Analyst. This role offers a varied mix of hands-on laboratory work and administrative responsibilities, supporting Cytocell FISH probe technical files.
What you’ll be doing for us:
Core
- Work with clinical and/or biological data and materials, ensuring accurate handling, tracking, and documentation
- Responsible for an assigned proportion of clinical/analytical project work
- Collaborate with internal teams & external labs or companies to support project specific sample requests in line with internal procedures and external regulations
- Contribute to the Quality Management System and infrastructure of the department by providing input into internal protocols and implementation of CAPAs, change controls and improvements
- Accurately follow SOPs and defined processes
- Maintain high levels of accuracy and attention to detail in all tasks and outputs
- Conduct data validation and/or quality checks prior to reporting any data
- Support high-volume report generation within defined timelines
- Contribute to audits and implement corrective actions and improvements
- Review marketing materials for scientific and clinical accuracy
- To complete any other tasks as commensurate with the level and nature of the post as delegated by the line manager.
As Required
- Responsible for the timely procurement of samples
- Analysis of haematological and FFPE specimens using manual microscopes and automated software
- Cover additional laboratory duties including biological sample culturing and harvesting (e.g., peripheral blood samples), image capture, receipt and logging of external samples, maintenance and use of internal samples and accurate upkeep of laboratory records
- Karyotyping/chromosome identification using reverse DAPI analysis or G-banding
- Responsible for setting up HTA projects in collaboration with project owner
- Run and monitor automated reporting workflows (e.g. R-based pipelines)
- Identify and resolve issues in the report generation (e.g. input data or processing errors), escalating more complex problems as needed
- Contribute to risk management activities, including maintaining documentation in line with ISO 14971
- Support periodic risk reviews and updates as part of product lifecycle management
- Conduct literature reviews to support clinical evidence
- Contribute to development of Scientific Validity reports and other clinical evidence documentation
- Support preparation and review of clinical and regulatory documentation
- Provide support in the validation of equipment and software as appropriate for the team.
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What we are looking for in you
Essential
- Background in a science related subject
- Experience of working in a GLP environment
- Knowledge of the human tissue act
- Previous experience of working with samples
- Strong understanding of biosafety, chain of custody, and regulatory requirements
- Strong computer literacy, including confidence using tools such as Excel for data handling and organisation
- High level of attention to detail, with the ability to check data and outputs for accuracy and consistency
- Good organisational and time management skills, with the ability to manage multiple tasks and meet deadlines
- Comfortable working with data, including maintaining accurate records and handling information appropriately
- Ability to work independently on routine tasks, while knowing when to seek support
- Able to work accurately and efficiently in a high-volume, process-driven, and protocol-driven environment
- Good document practice
- Excellent communication skills, both verbally and written
- Ability to train others.
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Desirable
- Knowledge of FISH and or other cytogenetics techniques
- Exposure to R or other data analysis tools (e.g. running scripts, basic troubleshooting)
- Ability to identify and resolve issues in data or automated reporting workflows, with support where needed
- Awareness of data validation or quality control processes
- Experience or awareness of clinical diagnostics or laboratory environments
- Experience supporting data collection, analysis & reporting
- Exposure to project coordination or workflow tracking
- Exposure to clinical evidence generation, literature review, or scientific writing
- Awareness of risk management processes or standards (e.g. ISO 14971)
- Experience supporting clinical or regulatory documentation
- Experience in equipment/software validation.
In return you will receive:
- Competitive salary
- Pension Scheme (10% non-contributory)
- Private Health Insurance
- Private Dental Insurance
- Group Income Protection
- Group Life Assurance
- 25 days holiday plus UK bank holidays
- High Street Discount Scheme.
Application
Application is via CV and a one-page covering letter outlining your suitability for the role, salary expectations and notice period.
Please note that we will need to establish your right to work during the recruitment process.
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