Global Regulatory Submissions Lead

Medpace; Stirling; On-site; GBP 55,000 - 85,000; Full time

Benefits offered by this job

Competitive compensation

Health benefits

Retirement benefits

PTO benefits

WFH after training

Social events

Job summary

Medpace is seeking a Senior Start-Up professional to lead global start-up activities, ensuring timely submission and quality control of essential documents. The role involves preparing informed consent forms, reviewing European regulatory requirements, and supporting bid defenses, capabilities meetings, and audits.

The ideal candidate has extensive clinical research experience, CRO exposure, and strong communication and leadership skills to drive cross-functional collaboration.

Qualifications

• Extensive experience in clinical research, preferably with a CRO.
• Experience may include CRA or project management.
• Knowledge of Clinical Trial Applications within Europe.
• Strong oral and written communication; team oriented with leadership.

Responsibilities

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

Skills

Clinical research experience

CRO experience

Communication skills

Leadership

Job description

Medpace is seeking a Senior Start-Up professional to lead global start-up activities, ensuring timely submission and quality control of essential documents. The role involves preparing informed consent forms, reviewing European regulatory requirements, and supporting bid defenses, capabilities meetings, and audits.

The ideal candidate has extensive clinical research experience, CRO exposure, and strong communication and leadership skills to drive cross-functional collaboration.