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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 with excellent career development.
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 sometimes lead to job opportunities that aren't even advertised.
✨Tip Number 2
Prepare for interviews by brushing up on your QC knowledge and the specific requirements of the role. We recommend practising common interview questions and having examples ready that showcase your attention to detail and communication skills.
✨Tip Number 3
Don’t forget to follow up after interviews! A quick thank-you email can leave a lasting impression and show your enthusiasm for the role. Plus, it keeps you on their radar.
✨Tip Number 4
Apply through our website for the best chance of getting noticed. Tailor your application to highlight your relevant experience as a QC Reviewer, and make sure to showcase your ability to manage multiple tasks independently.
We think you need these skills to ace Quality Control Reviewer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that match the Quality Control Reviewer role. Highlight any relevant QC or regulatory writing experience, and don’t forget to mention your attention to detail!
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 background makes you a perfect fit for our team at Bioscript. Keep it engaging and personal.
Showcase Your Communication Skills: As a QC Reviewer, strong communication is key. In your application, give examples of how you've effectively collaborated with others in past roles. This will show us you can work well with our team!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re keen on joining our team!
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, like clinical study reports and regulatory submissions. Brush up on any specific guidelines or templates that Bioscript uses, as this will show your attention to detail and readiness for the role.
✨Showcase Your QC Experience
Be prepared to discuss your previous experience in quality control or regulatory writing. Have specific examples ready that highlight your ability to manage multiple projects, resolve issues, and ensure compliance with standards. This will demonstrate your capability to handle the responsibilities of the role.
✨Communicate Clearly
Strong communication skills are key for this position. Practice articulating your thoughts clearly and concisely, especially when discussing how you collaborate with document authors and team members. This will help convey your ability to work effectively within a team.
✨Ask Insightful Questions
Prepare some thoughtful questions about the company culture, team dynamics, or specific QC processes at Bioscript. This not only shows your interest in the role but also gives you a chance to assess if the company is the right fit for you.