At a Glance
- Tasks: Coordinate regulatory submissions for clinical trials and ensure compliance with regulations.
- Company: Join Medpace, a leading clinical research organisation making a real impact in healthcare.
- Benefits: Enjoy flexible work, competitive pay, and great career growth opportunities.
- Other info: Dynamic office environment in London with a focus on professional development.
- Why this job: Be part of a mission-driven team improving lives through innovative medical research.
- Qualifications: Bachelor's degree in Life Sciences and experience with regulatory documentation required.
The predicted salary is between 36000 - 60000 £ 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 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.
Medpace Overview
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I‑IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti‑viral and anti‑infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Medpace Perks
- 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
Awards
Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024. Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility.
What To Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
Regulatory Submissions Coordinator (Study Start Up) employer: Medpace
Join our dynamic Clinical Operations team in London, where we prioritise employee growth and foster a collaborative work culture. As a Clinical Trial Site Relationship Coordinator, you'll benefit from ongoing professional development opportunities while working in a vibrant environment that values strategic relationships and innovative solutions in clinical research. Enjoy the unique advantage of reduced travel while making a meaningful impact in the field of clinical trials.
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 industry, attend relevant events, and engage with professionals on platforms like LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching Medpace and understanding their mission and values. We want to see that you’re genuinely interested in the role and the company. Practice common interview questions and think about how your experience aligns with the responsibilities of a Regulatory Submissions Coordinator.
✨Tip Number 3
Showcase your skills! Bring along examples of your previous work, especially any regulatory documentation you’ve prepared or submitted. We love seeing tangible evidence of your expertise and attention to detail, so don’t hold back!
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows us that you’re proactive and serious about joining our team at Medpace. Let’s make it happen!
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 mission at Medpace. 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. When submitting your application, double-check for any typos or errors. We appreciate candidates who take the time to ensure their submissions are polished and professional.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the info you need about the role and our company culture there!
How to prepare for a job interview at Medpace
✨Know Your Regulations
Make sure you brush up on the latest UK regulatory guidelines and compliance requirements. Being able to discuss these confidently will show that you're not just familiar with the role but also proactive about staying updated.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've successfully prepared, reviewed, or submitted regulatory documentation. Highlighting your experience with Ethics Committees and Regulatory Agencies will set you apart from other candidates.
✨Organisational Skills Matter
Since this role requires excellent organisational skills, be ready to discuss how you prioritise tasks and manage deadlines. You might even want to share a time when your attention to detail made a significant difference in a project.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions that show your interest in the company and the role. Inquire about their current projects or how they handle changes in regulations. This demonstrates your enthusiasm and commitment to the position.
