At a Glance
- Tasks: Coordinate regulatory submissions for clinical trials and ensure compliance with regulations.
- Company: Join a leading clinical operations team at Medpace in London.
- Benefits: Enjoy flexible work, competitive pay, and great career growth opportunities.
- Other info: Dynamic office environment with a focus on employee wellness and appreciation.
- Why this job: Make a real impact in clinical trials while advancing your career in life sciences.
- Qualifications: Bachelor's degree in Life Sciences and experience with regulatory documentation required.
The predicted salary is between 35000 - 45000 € per year.
Our clinical operations activities are growing rapidly, and we are currently seeking an experienced Regulatory Submissions Coordinator to join our Clinical Operations team in the UK. This position plays a key role in the clinical trial management process at Medpace. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Please note that this is an office-based position in London.
Responsibilities:
- Prepare, review, and file initial clinical trial applications to regulatory authorities;
- Prepare and submit responses to queries and amendments to clinical trial applications;
- Ensure submissions comply with applicable regulations and guidance documents;
- Advise team members on changing regulations and compliance requirements;
- Maintain the Clinical Trial Management System and ensure timely filing of documents;
- Collection of essential documents and preparation of essential documents packages for drug release.
Qualifications:
- A minimum of a Bachelor's degree is required (preferably in a Life Sciences field);
- Experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies, including formulating responses to queries;
- Relevant working experience at a CRO, Pharmaceutical Company, or an investigative site;
- Knowledge of regulatory guidelines in the UK;
- Excellent organizational and prioritization skills;
- Used to working independently with a proactive approach;
- Knowledge of Microsoft Office;
- Great attention to detail and excellent oral and written communication skills.
Benefits:
- Flexible work environment;
- Competitive compensation and benefits package;
- Competitive PTO packages;
- Structured career paths with opportunities for professional growth;
- Company-sponsored employee appreciation events;
- Employee health and wellness initiatives.
Regulatory Submissions Coordinator (Study Start Up) employer: Medpace, Inc.
At Medpace, we pride ourselves on being an excellent employer, offering a dynamic work environment in London where your expertise as a Regulatory Submissions Coordinator can truly shine. With a strong focus on employee growth, we provide structured career paths, competitive compensation, and a flexible work culture that values health and wellness initiatives, ensuring that you can thrive both personally and professionally.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Submissions Coordinator (Study Start Up)
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical operations field, especially those who have experience with regulatory submissions. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of UK regulatory guidelines. We recommend creating a cheat sheet of key points to discuss, so you can impress the hiring team with your expertise and confidence.
✨Tip Number 3
Showcase your organisational skills during the interview. Bring examples of how you've managed complex documentation or compliance tasks in the past. This will demonstrate that you're the perfect fit for the role of Regulatory Submissions Coordinator.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive and engaged with our company.
We think you need these skills to ace Regulatory Submissions Coordinator (Study Start Up)
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Submissions Coordinator role. Highlight your experience with regulatory documentation and any relevant qualifications. We want to see how your background fits perfectly with 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 clinical operations and how your skills align with our needs. Keep it engaging and personal – we love to see your personality come through!
Showcase Your Attention to Detail:In this role, attention to detail is key. Make sure your application is free from typos and errors. We appreciate candidates who take the time to double-check their work, so show us you’re meticulous right from the start!
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 – just follow the prompts and submit your materials!
How to prepare for a job interview at Medpace, Inc.
✨Know Your Regulations
Make sure you brush up on the latest UK regulatory guidelines. Being able to discuss specific regulations and how they apply to clinical trial submissions will show that you're not just familiar with the basics, but that you’re genuinely engaged with the field.
✨Showcase Your Experience
Prepare examples from your previous roles where you successfully prepared and submitted regulatory documentation. Highlight any challenges you faced and how you overcame them, as this will demonstrate your problem-solving skills and experience in a real-world context.
✨Organisational Skills Matter
Since this role requires excellent organisational skills, be ready to discuss how you manage multiple tasks and deadlines. You could even share a specific system or tool you use to keep everything on track, which will illustrate your proactive approach.
✨Communicate Clearly
Practice articulating your thoughts clearly and concisely. Given the importance of communication in this role, consider doing mock interviews with a friend or using video recordings to refine your delivery and ensure you come across as confident and articulate.
