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For Companies At a Glance
- Tasks: Ensure quality and compliance of regulatory documents through detailed reviews and collaboration.
- Company: Bioscript Group, a leader in pharmaceutical support with a focus on innovation.
- Benefits: Generous holiday, health coverage, community engagement days, and career development opportunities.
- Why this job: Join a dynamic team making a real impact in the pharmaceutical industry.
- Qualifications: Experience in quality control or regulatory writing, with strong attention to detail.
- Other info: Hybrid or remote work options available, fostering a flexible work-life balance.
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 practising common questions related to quality control and regulatory writing. We recommend using the STAR method (Situation, Task, Action, Result) to structure your answers and showcase your experience effectively.
✨Tip Number 3
Showcase your attention to detail! During interviews, be ready to discuss specific examples where you caught errors or improved processes. This is key for a Quality Control Reviewer role, so let your skills shine!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team at Bioscript.
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 effectively communicated in past roles.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive 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, brush up on the types of documents you'll be reviewing, like clinical study reports and protocols. Familiarise yourself with the specific standards and templates used by Bioscript Group to show that you understand their processes.
✨Showcase Your Attention to Detail
During the interview, highlight your experience in quality control and document publishing. Be ready to discuss specific examples where your attention to detail made a difference in ensuring accuracy and compliance in previous roles.
✨Communicate Effectively
Since collaboration is key in this role, practice articulating how you've worked with writers and project managers in the past. Use clear examples to demonstrate your strong communication skills and how you resolve QC findings collaboratively.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving abilities. Prepare for scenarios where you might need to manage competing projects or flag potential issues. Think about how you would prioritise tasks and communicate with your team to keep everything on track.