At a Glance
- Tasks: Prepare and submit clinical trial applications while ensuring compliance with regulations.
- Company: Join Medpace, a leading clinical research organisation dedicated to advancing medical therapeutics.
- Benefits: Enjoy competitive pay, health benefits, and opportunities for professional growth.
- Other info: Dynamic office environment with mentorship and clear career advancement paths.
- Why this job: Make a real impact in clinical research and work with industry experts.
- Qualifications: Bachelor's degree in Life Sciences and experience with regulatory documentation required.
The predicted salary is between 36900 - 45100 £ 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) providing 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 the advancement of clinical research.
Why Medpace?
- Purpose-Driven Work: Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence.
- Collaborative Culture: Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
- Continuous Growth & Development: Office based environment with on-site mentors, defined career paths with clear advancement opportunities, industry renowned onboarding and training programs designed to accelerate professional development, ongoing training and continuous learning opportunities throughout your career, an environment that encourages employees to influence change, contribute ideas, and grow quickly.
Other Employee Benefits
- Competitive compensation programs that recognize and reward performance;
- Comprehensive health, wellness, retirement, and PTO benefits;
- Office based culture with occasional WFH that provides flexibility for eligible positions after training;
- Company-sponsored social events.
Please note benefits may vary based on country.
What to Expect Next
A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.
Experienced Study Start-Up Coordinator in City of London employer: Medpace, Inc.
Medpace, Inc. is an excellent employer for those looking to kickstart their career in clinical trials, offering comprehensive onboarding and training that empowers you to become a data monitoring expert. With a strong emphasis on cross-functional collaboration and a supportive work culture, employees are encouraged to grow and develop their skills in a dynamic environment. Located in a vibrant office setting, Medpace provides a unique opportunity to contribute meaningfully to impactful projects while enjoying a fulfilling work-life balance.
