Senior Site Start-Up & Regulatory Submissions Lead

Syneos Health, Inc.; Gauteng; On-site; ZAR 600 000 - 800 000; Full time

Job summary

A leading biopharmaceutical solutions organization in Gauteng seeks a Local Submissions Specialist to ensure quality deliverables, manage regulatory submissions, and support the site's start-up process. The ideal candidate will have a Bachelor's Degree and a strong understanding of clinical trials, exceptional organizational skills, and the ability to manage multiple project budgets. This role requires effective communication and problem-solving skills.

Qualifications

• Detailed understanding of clinical trial process across Phases II-IV and ICH GCP.
• Ability to understand clinical protocols and associated study specifications.
• Demonstrated ability to work independently as well as part of a team.

Responsibilities

• Responsible for quality deliverables at the country level.
• Monitors financial aspects of the project.
• Prepares and submits regulatory applications as required.

Skills

Strong organizational skills

Strong written and verbal communication

Problem-solving skills

Ability to manage multiple project budgets

Education

Bachelor's Degree

Job description

A leading biopharmaceutical solutions organization in Gauteng seeks a Local Submissions Specialist to ensure quality deliverables, manage regulatory submissions, and support the site's start-up process. The ideal candidate will have a Bachelor's Degree and a strong understanding of clinical trials, exceptional organizational skills, and the ability to manage multiple project budgets. This role requires effective communication and problem-solving skills.