Global Regulatory Submissions Lead

Medpace; Stirling; Hybrid; GBP 60,000 - 90,000; Full time

Benefits offered by this job

Office-based culture

Occasional WFH after training

On-site mentors

Job summary

Medpace is seeking a full-time, office-based Regulatory Submissions Manager to join our Clinical Operations team. This position plays a key role in the clinical trial management process at Medpace and offers opportunities to use your regulatory expertise and grow your career.

Responsibilities include managing global start-up, quality checks on submission documents, preparing informed consent forms, reviewing regulations for proactive solutions, and presenting at bid defenses and audits.

Qualifications

• Extensive experience in clinical research, preferably with a CRO.
• Experience with Clinical Trial Applications within Europe.
• Strong oral and written communication skills.
• Team oriented approach and strong leadership skills.

Responsibilities

• Efficiently manage and successfully execute all aspects of global start-up.
• Perform quality checks on submission documents and site essential documents.
• Prepare and approve informed consent forms.
• Review pertinent regulations to develop proactive solutions to start-up issues and challenges; and
• Present during bid defenses, general capabilities meetings, and audits.

Skills

Regulatory submissions

Clinical research experience

Communication skills

Leadership

Job description

Medpace is seeking a full-time, office-based Regulatory Submissions Manager to join our Clinical Operations team. This position plays a key role in the clinical trial management process at Medpace and offers opportunities to use your regulatory expertise and grow your career.

Responsibilities include managing global start-up, quality checks on submission documents, preparing informed consent forms, reviewing regulations for proactive solutions, and presenting at bid defenses and audits.