Country Approval Specialist II/III

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you will play a key role in the management, preparation, review, and coordination of Country Submissions in alignment with the global submission strategy. In addition, you will support critical study start-up activities, including coordination with sites on agreements and budgets to ensure timely site activation. As a Country Approval Specialist, you will ensure submissions and start-up activities are executed efficiently and aligned with both regulatory requirements and study timelines.

What You’ll Do:

• Prepares, reviews, and coordinates, under guidance, local regulatory submissions (MoH, EC, and other applicable national requirements) in alignment with global submission strategy
• Provides, under guidance, local regulatory strategy advice (MoH and/or EC) to internal stakeholders
• Acts as a key country-level contact for ethical and regulatory submission-related activities
• Coordinates with internal functional departments to align submission activities with site start-up timelines and study milestones
• Supports site start-up activities, including coordination and negotiation of site agreements, budgets, and payment schedules to facilitate timely site activation
• Reviews and coordinates site contract and budget-related documents, working closely with internal stakeholders and sites
• Engages with investigators and site personnel for submission and start-up related activities as needed
• Supports feasibility activities and ensures alignment with study timelines
• Ensures accurate and timely entry and maintenance of study information in tracking systems
• Prepares, maintains, and ensures compliance of local study files in accordance with SOPs and client requirements
• Maintains up-to-date knowledge of applicable SOPs, regulatory requirements, and guidelines

Education and Experience Requirements:

• Bachelor’s degree or equivalent in a relevant field
• Minimum 3+ years of experience in clinical research, regulatory, or study start-up roles
• Experience supporting site start-up activities, including contract and budget negotiation, is preferred
• Equivalent combination of education, training, and experience will be considered

Knowledge, Skills and Abilities:

• Effective oral and written communication skills
• Excellent interpersonal and stakeholder management skills
• Strong attention to detail and quality of documentation
• Strong negotiation skills, particularly in site contracts and budget discussions
• Basic understanding of clinical trial start-up processes, including regulatory submissions and site activation activities
• Ability to coordinate across multiple stakeholders and timelines
• Good computer skills and ability to learn relevant systems
• Good English language and grammar skills
• Basic knowledge of medical terminology and therapeutic areas
• Ability to work independently and within a team environment
• Basic knowledge of applicable regional and local regulatory requirements

Working Conditions and Environment:

• Work is performed in a flexible (hybrid) environment, with occasional on-site presence at the client’s office as needed