At a Glance
- Tasks: Prepare and submit clinical trial applications and responses to regulatory queries.
- Company: Join Medpace's Clinical Operations team, a leader in clinical trial management.
- Benefits: Enjoy a flexible work environment and competitive compensation with structured career paths.
- Other info: This is an office-based position located in London.
- Why this job: This role offers the chance to grow your career in a rapidly expanding clinical operations environment.
- Qualifications: Requires a Bachelor's degree in Life Sciences and experience with regulatory documentation.
The predicted salary is between 40000 - 50000 £ per year.
Department: Site Activation & Maintenance
Location: London
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 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
Regulatory Submissions Coordinator (Study Start Up) in London employer: Medspace
Medpace is based in London and offers a competitive PTO package along with employee health initiatives. The company values professional growth and hosts appreciation events for its employees.
