420 jobs for “Pharmaceutical Quality Assessor”
Manage regulatory activities for clinical trial applications across an assigned portfolio, working with study teams, country leads and cross-functional partners. Anticipate regulatory risks, coordinate responses to Health Authority queries and maintain product information in compliance systems, while contributing to automation and simplification initiatives.
Lead the authoring of high-complexity regulatory documents and act as Program Writer for complex programmes, overseeing writing strategy, coordination, planning and resourcing. Provide expert guidance to clinical trial and submission teams, shape data analysis planning, and champion best practices, new technologies and AI tools to improve writing quality and efficiency.
Artificial Intelligence
Provides scientific and medical expertise at study level across early- and late-phase hepatology assets, leading protocol and study document development, serving as medical monitor for Phase 1–4 trials, and interpreting efficacy, safety and biomarker data. Works within cross-functional global study teams and the Clinical Matrix Team, with informal coaching of less experienced clinical scientists and no formal line management.
GSK · 10000+ people · Public
Leads global medical writing for the Respiratory, Immunology and Inflammation portfolio, directing strategy, resourcing and delivery of regulatory-compliant clinical documentation to accelerate submissions. Drives innovation and digital/AI adoption, manages vendor oversight and talent development, and partners with senior R&D stakeholders on governance and process improvement.
AI · Content Management Systems
IQVIA
Supports the Centralized Monitoring Lead in building study-specific monitoring strategies, programming quality tolerance limits, key risk indicators and data visualisations on the Cluepoints platform. Handles platform setup, scheduled refreshes, specification documents and peer reviews, working directly with a sponsor on a dedicated project. Requires strong SAS macro skills and prior data management experience.
Cluepoints · SAS · EDC Systems +1
IQVIA
Leads end-to-end delivery of regional and global clinical trials embedded within a sponsor's team, managing timelines, budgets, risk and cross-functional groups. Also supports bid defence presentations, vendor management and financial forecasting, mentoring less experienced project team members.
IQVIA
Eurofins
Perform routine, non-routine and stability testing on finished pharmaceutical products at a client site, using HPLC, Dissolution, Karl Fischer and UV techniques. The role also covers technology transfers, analytical validation, GMP data review and OOS investigations, working within a managed services team embedded at the client's facility.
HPLC · Dissolution · Karl Fischer +4
Evotec
Acts as the single front door between Evotec's Drug Discovery Platforms and the global In Silico & AI organisation, owning demand, relationships and the in silico roadmap. Translates platform science needs across DMPK, ADME/Tox, predictive safety, screening and omics into prioritised AI requirements, then orchestrates delivery across capability units. Carries a commercial mandate, contributing to client proposals, pricing and evidencing value such as margin uplift and cycle time.
Eurofins
Performs routine, non-routine and stability testing of biologic drug substances in a client's Analytical Service Department, running ELISA, cell-based and Biacore assays and capturing data in laboratory software and electronic notebooks. Generates and reviews GMP-compliant documentation, SOPs and protocols, supports method development and validation, and handles out-of-specification investigations while liaising with internal and external clients.
Biacore · Vi-Cell · Microsoft Office
Thermo Fisher Scientific
Performs complex sample preparation and quantitative analysis of small molecules and biotherapeutics using instrumentation such as GC-MS, ICP-OES, HPLC and LC-MS, supporting both GMP and non-GMP stability studies. Works largely independently to set up, maintain and troubleshoot analytical instrumentation, interpret data for technical validity and compliance, and report results to client teams. Based full-time onsite at a pharmaceutical client site as part of a functional service provider partnership.
GC-MS · ICP-OES · HPLC +2
Thermo Fisher Scientific
Lead medical writer dedicated to a single client, authoring and reviewing clinical study reports, protocols, IBs, INDs and MAAs while advising on document strategy and regulatory requirements. Provides senior review, mentoring and training to junior writers and program managers, and leads process improvement initiatives. Therapeutic experience in neurology, immunology, oncology or vaccines is valued.
Moderna · 1001–5000 people · Late stage
Develops, validates and runs ligand-binding and cell-based bioanalytical assays generating pharmacodynamic and immunogenicity data for clinical mRNA programmes. Works in a GcLP-regulated lab using Thermo Watson LIMS and electronic notebooks, handling clinical samples, critical reagents, SOPs and validation reports while partnering with Clinical Operations and Sample Management.
Thermo Watson LIMS · Watson LIMS · LabVantage eLBN +1
CSL · 10001+ people · Public
Leads a cross-functional Clinical Development Team as the lead scientific expert, owning the clinical strategy, plan and medical monitoring for immunoglobulin programs. Accountable for clinical content of regulatory submissions and study documents, and serves as medical monitor across trials in a matrixed environment.
CSL · 10001+ people · Public
Leads the cross-functional Clinical Development Team as lead scientific expert, owning the Clinical Development Plan and integrating internal and external contributions into program strategy. Serves as medical monitor, authors key regulatory and study documents, and presents to safety and review committees.
Isomorphic Labs · 201–500 people · Series A
Lead DMPK strategy across drug discovery projects, designing screening cascades and mechanistic experiments while integrating DMPK, PD and toxicology data for dose and safety predictions. Work closely with AI/ML platform teams to optimise computational ADME models and author regulatory sections, in a hybrid Cambridge, MA role.
Python · R
