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- Tasks: Conduct quality control reviews and ensure accuracy of regulatory documents.
- Company: Bioscript Group, a leader in pharmaceutical support services.
- Benefits: Generous holiday, health benefits, and opportunities for community involvement.
- Why this job: Join a dynamic team and make a real impact in the pharmaceutical industry.
- Qualifications: Experience in QC reviewing or regulatory writing with strong attention to detail.
- Other info: Hybrid or remote work options available, fostering a diverse and inclusive workplace.
The predicted salary is between 36000 - 60000 £ per year.
Role: Quality Control Reviewer
Business Unit: Bioscript Regulatory Writing
Location: Macclesfield / London (Hybrid or remote – UK)
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.
Quality Control Reviewer employer: Bioscript Group
Contact Detail:
Bioscript Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Control Reviewer
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those who work at Bioscript or similar companies. A friendly chat can open doors and give you insider info that could help you stand out.
✨Tip Number 2
Prepare for interviews by brushing up on your QC knowledge and the specific documents you'll be working with. Show us you know your stuff and can handle the pressure of managing multiple projects!
✨Tip Number 3
Don’t just apply anywhere; focus on our website! Tailor your application to highlight how your experience aligns with the role of Quality Control Reviewer. We love seeing candidates who are genuinely interested in joining our team.
✨Tip Number 4
Follow up after your interview! A quick thank-you email can leave a lasting impression. It shows us you're keen and professional, which is exactly what we look for in a Quality Control Reviewer.
We think you need these skills to ace Quality Control Reviewer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Control Reviewer role. Highlight relevant experience in QC and regulatory writing, and don’t forget to showcase your attention to detail – it’s key for this position!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality control and how your skills align with our mission at Bioscript. Keep it concise but impactful!
Showcase Your Communication Skills: Since strong communication is essential for this role, make sure to demonstrate your ability to collaborate and resolve issues in your application. Share examples of how you've worked with teams in the past.
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you’re considered for the role. Plus, it’s super easy!
How to prepare for a job interview at Bioscript Group
✨Know Your Documents
Before the interview, make sure you’re familiar with the types of documents you'll be reviewing. Brush up on clinical regulatory documents like protocols and study reports. This will show that you understand the role and can discuss specifics confidently.
✨Highlight Your Attention to Detail
Since this role requires a keen eye for detail, prepare examples from your past work where you caught errors or improved document quality. Be ready to explain how your attention to detail has positively impacted previous projects.
✨Showcase Your Communication Skills
Effective communication is key in this role. Think of instances where you collaborated with writers or team members to resolve issues. Be prepared to discuss how you approach feedback and ensure clarity in your communications.
✨Understand the QC Process
Familiarise yourself with quality control processes and best practices in regulatory writing. Being able to discuss these concepts will demonstrate your readiness for the role and your proactive approach to ensuring compliance and accuracy.