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- Tasks: Conduct thorough quality checks on clinical regulatory documents to ensure accuracy and compliance.
- Company: Join Freyr, a fast-growing innovator in regulatory solutions for the Life Sciences industry.
- Benefits: Enjoy a competitive salary, professional development, and a dynamic work environment.
- Why this job: Make a real impact in the healthcare sector by ensuring the highest quality in clinical documentation.
- Qualifications: Attention to detail and a passion for regulatory compliance are essential.
- Other info: This is a one-year fixed-term role with excellent career growth opportunities.
The predicted salary is between 36000 - 60000 £ per year.
Freyr is a fast‐growing, innovative company specializing in providing end‐to‐end regulatory solutions and services for the Life Sciences industry. With a commitment to excellence and innovation, we assist pharmaceutical, medical device and biotech companies in navigating regulatory compliance.
Location: United Kingdom
Duration: 1 year fixed term employment
Job Description:
- Comprehensive QC review of clinical sections of regulatory documents, including but not limited to: IBs, Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologic License Applications (BLAs), Clinical Trial Applications (CTAs), Marketing Authorization Applications (MAAs), briefing packages for regulatory agency meetings/advice, including verification of all references and source data, to achieve the highest quality from a technical, regulatory, and compliance perspective.
- Verify internal consistency within a document and across related documents.
- Comprehensive content QC of clinical data/reports.
- Documentation of QC findings in the appropriate manner/tool.
- Content QC activity is applicable for all therapeutic areas, development phases, modalities and geographic regions.
- Checking of data presented in text and tables/figures against source documents for consistency and accuracy.
- Verification of the data/content (100%) including text, tables, and figures as per the source documents.
- Review for grammar, punctuation, spelling and compliance with specified styles/standards.
- Maintenance of the QC records and checklists.
Medical Reviewer - Clinical QC in London employer: Freyr Solutions
Contact Detail:
Freyr Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Medical Reviewer - Clinical QC in London
✨Tip Number 1
Network like a pro! Reach out to professionals in the Life Sciences industry on LinkedIn or at events. We can leverage our connections to get insights and maybe even a foot in the door.
✨Tip Number 2
Prepare for interviews by practising common questions related to clinical QC. We should also be ready to discuss specific regulatory documents we've worked with, showing our expertise and attention to detail.
✨Tip Number 3
Follow up after interviews! A quick thank-you email can go a long way. We can express our enthusiasm for the role and reiterate how our skills align with their needs.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. We’ve got some great roles waiting for talented individuals like you!
We think you need these skills to ace Medical Reviewer - Clinical QC in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Medical Reviewer role. Highlight your experience with regulatory documents and any relevant QC work you've done. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about the Life Sciences industry and how you can contribute to our mission at Freyr. Keep it concise but impactful!
Showcase Your Attention to Detail: Since this role involves comprehensive QC reviews, it's crucial to demonstrate your attention to detail. Mention specific examples where you've caught errors or improved document quality in your previous roles.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at Freyr Solutions
✨Know Your Regulatory Stuff
Make sure you brush up on the key regulatory documents like INDs, NDAs, and BLAs. Familiarise yourself with the specific requirements for each type of application, as this will show your potential employer that you understand the nuances of the role.
✨Showcase Your Attention to Detail
Since the job involves comprehensive QC reviews, be prepared to discuss examples from your past work where your attention to detail made a difference. Bring along any relevant documents or reports that highlight your ability to catch errors and ensure compliance.
✨Practice Your Communication Skills
You'll need to document QC findings clearly and concisely. Practise explaining complex information in simple terms, as this will demonstrate your ability to communicate effectively with both technical and non-technical stakeholders.
✨Prepare Questions About the Company
Research Freyr and come up with insightful questions about their approach to regulatory solutions. This shows your genuine interest in the company and helps you assess if it’s the right fit for you.
