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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 dynamic work environment with opportunities for growth and professional development.
- Why this job: Make a real impact in the regulatory field while working with passionate professionals.
- Qualifications: Attention to detail and a passion for regulatory compliance are essential.
- Other info: Be part of an exciting journey as we shape the future of regulatory services together.
The predicted salary is between 36000 - 60000 £ per year.
About Freyr
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 the complexities of regulatory compliance.
Why Freyr?
At Freyr, we believe in fostering a collaborative and dynamic work environment that empowers our team to make a real impact. As we expand our footprint, we are on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory services.
Join Our Team:
If you’re ready to embark on a journey of growth and innovation, connect with us to explore the exciting opportunities awaiting you at Freyr. Together, we can shape the future of regulatory solutions.
To Apply:
Please apply to this job post or you can visit our Careers page for more openings. Don’t miss this chance to be a part of Freyr’s expansion and make your mark in the world of regulatory services. Let’s redefine regulatory excellence together.
Position: Reviewer - Clinical QC
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 employer: Freyr Solutions
Contact Detail:
Freyr Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Medical Reviewer
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that Medical Reviewer role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory compliance and clinical documentation. We recommend practising common interview questions and even doing mock interviews with friends to boost your confidence.
✨Tip Number 3
Showcase your passion for the industry! During interviews, share your insights on current trends in regulatory services. We want to see your enthusiasm and how you can contribute to Freyr’s mission.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to stay updated on all openings and ensures your application gets the attention it deserves. Let’s make your dream job a reality together!
We think you need these skills to ace Medical Reviewer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Medical Reviewer role. Highlight relevant experience in regulatory compliance and quality control, 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 express your passion for the life sciences industry and explain why you’re excited about joining Freyr. Be sure to mention how your skills align with our mission of regulatory excellence.
Showcase Your Skills: In your application, make sure to highlight specific skills that are relevant to the role, like your experience with clinical documents and your ability to verify data accuracy. We want to see how you can contribute to our team!
Apply Through Our Website: Don’t forget to apply through our Careers page! It’s the best way to ensure your application gets noticed. Plus, you can check out other exciting opportunities while you’re there. Let’s redefine regulatory excellence together!
How to prepare for a job interview at Freyr Solutions
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulations and guidelines relevant to clinical trials and drug applications. Being able to discuss specific examples of your experience with documents like INDs or NDAs will show that you're not just familiar with the theory, but you can apply it in practice.
✨Showcase Your Attention to Detail
Since the role involves comprehensive QC review, be prepared to demonstrate your meticulousness. Bring examples of how you've caught errors in past projects or how you've ensured compliance in documentation. This will highlight your ability to maintain high standards.
✨Prepare for Scenario Questions
Expect questions that put you in hypothetical situations related to QC processes. Think about how you would handle discrepancies in data or what steps you'd take if you found a major error in a document. Practising these scenarios can help you articulate your thought process clearly.
✨Ask Insightful Questions
At the end of the interview, don’t shy away from asking questions about Freyr’s approach to regulatory challenges or their team dynamics. This shows your genuine interest in the company and helps you gauge if it's the right fit for you.