Financial Reviewer

Role: Quality Control Reviewer Business Unit: Bioscript Regulatory Writing Macclesfield / London (Hybrid or remote - UK) Established in 2005, Bioscript Group is formed from multiple, specialist businesses to support our global pharmaceutical clients; we draw on their multidisciplinary expertise to help navigate critical decisions at key points in the product lifecycle. Our scientific and strategic expertise helps our clients make better decisions. We provide medical communication services, market access consulting and regulatory writing support with deep domain expertise to effectively navigate complex disease areas. The role of the Quality Control Reviewer is to conduct quality control (QC) and other supportive activities to support delivery of accurate, compliant and submission-ready documents prepared by writers in Bioscript Regulatory Writing (including internal and external writers), or by clients. Perform QC review and manage QC projects in accordance with agreed upon timelines. Verify accuracy of document content using source documents including, but not limited to, clinical regulatory documents (e.g. protocols, clinical study reports, CIOMS reports, clinical summaries/overviews), statistical analysis plans and data tables, figures, and listings. Record QC findings and identify appropriate corrections to address findings. Collaborate with document authors and other team members (as needed) to resolve QC findings. Flag capacity or bottlenecks to the QC Manager so that resource can be allocated most efficiently. Efficiently manage competing projects, proactively flagging potential issues to the QC Manager. Support the Project Management team by monitoring the progress of all assigned projects against the agreed QC schedule and QC budget specification. Support the regulatory writing team (eg, supporting other QC Reviewers, editorial support for writers [eg, populating tables, drafting narratives etc). Understand QC and publishing processes and strategy, client procedures, and best practice for projects. Proofread, edit, compile, and publish regulatory documents according to BRW or client conventions and applicable regulatory and industry guidance. Previous experience working as a QC Reviewer / Regulatory Writer within an agency or pharmaceutical setting Attention to detail to ensure accuracy and quality in all deliverables 25 days holiday + bank holidays + winter shutdown + holiday purchase scheme ~ Enhanced maternity, paternity & adoption leave ~ Bonus Day off to be spent giving back to the community ~ Life Insurance and Critical Illness cover ~ Private Medical (Vitality for UK based colleagues) ~ Health cash plan or wellbeing allowance ~ International Employee Assistance Program