Role: Quality Control Reviewer
Business Unit: Bioscript Regulatory Writing
Location: Macclesfield / London (Hybrid or remote)
About Us
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 Opportunity
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.
Key Responsibilities
* 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.
* Verify internal consistency within a document and across related documents.
* Verify uniformity and compliance of documents with internal or client standards (e.g. document templates, style guide, publishing requirements).
* Record QC findings and identify appropriate corrections to address findings.
* Collaborate with document authors and other team members (as needed) to resolve QC findings.
* Proactively share knowledge and experience to support transfer of knowledge across the team.
* Take responsibility for ensuring optimum use of own time. 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.
* Ensure adherence to agreed client/Bioscript standard operating procedures.
About You
* Previous experience working as a QC Reviewer / Regulatory Writer within an agency or pharmaceutical setting
* Previous experience of document publishing preferred
* Attention to detail to ensure accuracy and quality in all deliverables
* Ability to take initiative and manage multiple tasks independently
* Strong communication skills
Our people are at the heart of our business
We are focused not just on delivering the exceptional for our clients, but for our teams too. We understand everyone is different and believe in treating everyone as an individual with opportunities to develop your skills and career around our disciplines.
Our benefits include:
* Salary which aligns with your experience and skillset
* 25 days holiday + bank holidays + winter shutdown + holiday purchase scheme
* Enhanced sick and compassionate leave
* Enhanced maternity, paternity & adoption leave
* Birthday charity donation to a charity of your choice
* 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
We are committed to creating an inclusive and diverse workplace. We encourage applications from all individuals who meet the minimum requirements of the role. If you require any reasonable adjustments during the application or interview process, please contact us via careers@bioscriptgroup.com or by calling 01625 908246.