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- Tasks: Review and compare infusion sets for gene therapy trials and provide regulatory justification.
- Company: Leading client in gene therapy clinical trials with a focus on innovation.
- Benefits: Flexible hours, competitive pay, and the chance to work on groundbreaking therapies.
- Why this job: Make a real difference in gene therapy by ensuring safe and effective delivery methods.
- Qualifications: Expertise in infusion sets and regulatory experience in EU/US submissions.
- Other info: Ad-hoc role with approximately 10 hours of work per month.
The predicted salary is between 13 - 16 £ per hour.
We are supporting a client conducting gene therapy clinical trials who is preparing an EU regulatory submission and requires specialist expertise in infusion set comparability. US clinical trials were completed using a pump and infusion set that underwent full in-use compatibility testing. However, this infusion set is not approved for use in the EU. An alternative pump and infusion set have been identified, and the client now requires expert support to assess comparability and provide a scientific and regulatory justification on whether a new in-use study can be avoided. An in-use study will run in parallel.
Key Responsibilities
- Review and compare materials, components, and design features of two infusion/giving sets
- Assess material compatibility and potential impact on gene therapy delivery
- Provide scientific and regulatory justification on infusion set comparability
- Advise cross-functional teams including regulatory and clinical stakeholders
Required Experience
- Strong expertise in infusion sets, giving sets, or drug–device combination products
- Experience with material compatibility and in-use considerations
- Regulatory experience supporting EU and/or US submissions
- Background in biologics or advanced therapies (gene therapy experience preferred)
Start Date: Immediate
Workload: Ad-hoc (approx. 10 hours per month)
Infusion set expert in London employer: Discover International
Contact Detail:
Discover International Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Infusion set expert in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the gene therapy and infusion set space. We all know that sometimes it’s not just what you know, but who you know that can land you that dream gig.
✨Tip Number 2
Show off your expertise! Prepare a portfolio or a presentation that highlights your experience with infusion sets and regulatory submissions. We want to see how you can bring value to the table, so make it shine!
✨Tip Number 3
Be proactive! Don’t wait for job postings to pop up. Reach out directly to companies involved in gene therapy and express your interest. We love when candidates take the initiative – it shows passion and commitment!
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we’re always on the lookout for talent that fits our needs, so don’t hesitate to hit that apply button!
We think you need these skills to ace Infusion set expert in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your expertise in infusion sets and any relevant regulatory experience. We want to see how your background aligns with the role, so don’t be shy about showcasing your skills!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this role. We love seeing passion and clarity, so make sure to connect your experience with the job description.
Showcase Relevant Experience: When filling out your application, focus on your experience with material compatibility and gene therapy. We’re looking for specific examples that demonstrate your knowledge and how you can contribute to our team.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the easiest way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen to join our team!
How to prepare for a job interview at Discover International
✨Know Your Stuff
Make sure you brush up on your knowledge of infusion sets and their components. Familiarise yourself with the specific materials and design features of both the existing and alternative sets. This will help you speak confidently about comparability and compatibility during the interview.
✨Regulatory Savvy
Since the role involves EU regulatory submissions, it’s crucial to understand the differences between EU and US regulations regarding infusion sets. Be prepared to discuss how your experience aligns with these requirements and how you can navigate the regulatory landscape effectively.
✨Showcase Your Experience
Highlight any previous work you've done with drug-device combination products or gene therapy. Use specific examples to demonstrate your expertise in material compatibility and in-use considerations, as this will show that you’re the right fit for the role.
✨Engage with Cross-Functional Teams
The job requires advising cross-functional teams, so be ready to discuss how you’ve collaborated with regulatory and clinical stakeholders in the past. Share examples of how you’ve communicated complex scientific concepts to non-experts, as this will showcase your ability to work well in a team.
