Regulatory Submissions Specialist — Clinical Trials

Medpace, Inc.; Stirling; Sur place; GBP 32 000 - 52 000; Plein temps

Avantages offerts par ce poste

Flexible work environment

Competitive compensation and benefits

Competitive PTO packages

Structured career paths

Company-sponsored events

Health and wellness initiatives

Résumé du poste

Medpace, Inc. is seeking a full-time, office-based Regulatory Submissions Coordinator to join our Clinical Operations team in Stirling. The role supports daily regulatory submissions activities, timelines, and documentation throughout the trial management process.

You will collect, review, assemble submissions, liaise with research sites, and ensure compliance with regulations. A life sciences degree and at least two years' experience are required, with strong Microsoft Office skills and

Qualifications

• Bachelor's degree in a Life Sciences field.
• At least 2 years of work experience as a Regulatory Submissions Coordinator.
• Hands-on experience preparing, reviewing, and submitting regulatory documentation.
• Knowledge of Microsoft Office.
• Excellent organization and communication skills.
• Great attention to detail.

Responsabilités

• Provide day-to-day departmental support activities to Regulatory Submissions Coordinators.
• Maintain database and spreadsheets as necessary to facilitate tracking and documentation of departmental activities.
• Collect, review, organize, and assemble regulatory start-up submissions.
• Perform other tasks as needed.
• Prepare, review, and file clinical trial applications.
• Communicate with research sites to collect all essential documents required before the site starts to enrol patients to participate in the clinical trial.
• Provide insightful input on regulatory submissions documents and maintain timelines for study start-up through both internal and external collaboration.
• Ensure submissions comply with applicable regulations and guidance documents.

Connaissances

Communication skills

Attention to detail

Organizational skills

Formation

Bachelor's degree in Life Sciences

Outils

Microsoft Office

Description du poste

Medpace, Inc. is seeking a full-time, office-based Regulatory Submissions Coordinator to join our Clinical Operations team in Stirling. The role supports daily regulatory submissions activities, timelines, and documentation throughout the trial management process.

You will collect, review, assemble submissions, liaise with research sites, and ensure compliance with regulations. A life sciences degree and at least two years' experience are required, with strong Microsoft Office skills and