Country Approval Specialist II/III

Job description

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