Integrates phenomics, transcriptomics, genomics and proteomics data to nominate and validate oncology targets and define precision oncology patient strategies. Partners cross-functionally with biologists, chemists, engineers and translational experts to build target data packages and pilot novel discovery methods, including agentic target packages and mechanism-of-action work.
Lead authoring and strategic planning for clinical and regulatory documents, including protocols, clinical study reports, briefing documents and submission dossiers. Manages end-to-end writing projects, coordinating contributors, timelines and quality checks, and acts as subject matter expert on medical writing standards, CTD structure and regulatory expectations while driving process improvement and audit readiness.
Lead authoring and strategic planning of clinical and regulatory documents such as protocols, clinical study reports, briefing documents and CTD submission dossiers. Manage end-to-end writing projects, coordinating contributors, timelines and quality checks, and act as subject matter expert on medical writing standards and regulatory expectations while driving process improvement and audit readiness.
Develops and executes global and regional regulatory strategies for oncology assets, ensuring optimal labelling and approvals while maintaining compliance. Works with the Global Regulatory Lead and cross-functional teams to shape development plans and support authority interactions and submissions across multiple regions.
Lead the Quality Systems & Compliance function within an aseptic compounding unit, owning the site QMS and ensuring GMP/GDP compliance and audit readiness. Oversee document control, CAPAs, deviations, complaints, nonconformances, risk management and internal audits, while reporting quality KPIs to the management team. Distinct for its hands-on leadership of investigations and continuous improvement in a regulated pharmaceutical manufacturing setting.
Lead product definition for technically complex point-of-care systems, managing a team of systems and requirements engineers. Drive requirements engineering, elicitation and evaluations, and support rapid resolution of technical issues. Fully site-based in Motherwell on a 12-month contract in the medical devices sector.
Perform analytical testing for batch release, stability studies and complaint investigations in a GMP/GLP-regulated pharmaceutical lab, using techniques such as HPLC and UV spectroscopy. Support OOS/OOT investigations, maintain Good Documentation Practices, review and issue GMP documentation, and help with calibration and equipment maintenance. A 12-month temp contract within a cross-functional QC team.
Leads regional or global regulatory strategy for development programs and marketed products, serving as a regulatory lead and primary contact with health authorities. Manages preparation, submission and approval of regulatory applications, advises teams on approval pathways and expedited routes, and monitors regulatory intelligence to inform strategy.
Provides safety science and pharmacovigilance support across the Roche portfolio, covering signal detection, benefit-risk assessment, ICSR case management and aggregate reporting such as DSUR and PBRER. The role also involves preparing CCDS, labelling, RMP and REMS documents and shaping drug safety input into clinical development strategy. Level is set by experience, working with a global team from the Welwyn office.
Lead the implementation of a brand-new Label and Secondary Packaging operation at the Harwell site, providing technical leadership to establish it from the ground up before building a high-performing maintenance and engineering function. Work across engineering, manufacturing and global teams on capital projects, commissioning, qualification and validation, while developing preventative maintenance strategies and GMP-compliant systems.
Leads EU regulatory strategy for oncology programmes, driving major submissions (MAA/CTR/IVDR/CTA), EMA and national health authority interactions, label negotiations and approvals. Chairs cross-functional Global Regulatory Strategy Team work, mentors members and owns regulatory documents, risk assessments and lifecycle planning within a global matrix.
A laboratory-based senior scientist role combining hands-on experimentation with modelling, simulation and digital tools to design and optimise manufacturing processes for oral and parenteral drug products in late-stage development. The position sits in a cross-functional process technology and engineering team, covering scale-up, technology transfer and CMC regulatory documentation.
Safety expert serving as global PV lead for gene therapy products across investigational and marketed phases, owning benefit-risk strategy, aggregate reports (PSURs, DSURs) and risk management plans. Also acts as medical monitor, providing clinical oversight, real-time AE/SAE review and signal detection in close collaboration with cross-functional teams and health authorities.
Lead CMC regulatory strategy for UK-manufactured and UK-licensed mRNA products across development, registration and post-approval lifecycle. Act as primary point of contact with the MHRA, oversee submissions and manufacturing change assessments, and shape global regulatory approaches across cross-functional matrix teams.
Leads end-to-end Clinical Systems migration initiatives such as CTMS, eTMF and study startup, from strategy and due diligence through implementation, cutover and legacy decommissioning. Oversees data migration programs, CRO integrations and GxP validation, managing vendors, stakeholders and a team of professionals while shaping the Clinical Systems roadmap.
