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.
- Other info: Hybrid or remote work options available, fostering a flexible work-life balance.
- Why this job: Join a dynamic team making a real impact in the pharmaceutical industry.
- Qualifications: Experience in QC reviewing or regulatory writing, with strong attention to detail.
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 in Leicester employer: Bioscript Group
Bioscript Group is an exceptional employer that prioritises the well-being and development of its employees, offering a supportive work culture in Macclesfield or London with flexible hybrid and remote options. With a comprehensive benefits package including generous holiday allowances, enhanced family leave, and a commitment to community engagement, we empower our Quality Control Reviewers to thrive both professionally and personally while contributing to impactful projects in the pharmaceutical sector.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Control Reviewer in Leicester
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We think you need these skills to ace Quality Control Reviewer in Leicester
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Bioscript Group!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Bioscript Group that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Bioscript Group!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Bioscript Group, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Bioscript Group
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Bioscript Group that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Bioscript Group’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
