Country Approval Associate

This is a fully remote position, open to applicants in Argentina.

📋 Description

• Prepare, review, and coordinate Country Submissions in accordance with global submission strategy and guidance.

• Assist in the preparation of submissions to the local Ministry of Health.

• Collaborate with internal departments on site start-up activities and submission schedules.

• Ensure that submission processes are in line with the critical path for site activation.

• Meet company target cycle times for site activations.

• Reach out to investigators for activities related to submissions as necessary.

• Serve as the primary country-level contact for Ethical and Regulatory submission matters.

• Work alongside start-up CRAs to create regulatory compliance review packages.

• Help develop country-specific Patient Information Sheets and Informed Consent Forms.

• Assist in negotiating grant budgets and payment schedules with sites.

• Enter and update trial status in tracking databases.

• Prepare, organize, and maintain local country study files and filing systems.

• Stay informed about PPD and client SOPs, directives, and current regulatory guidelines.

⛳️ Requirements

• Bachelor's degree or an equivalent qualification with relevant formal academic or vocational training.

• Prior experience ranging from 0 to 2 years is preferred.

• Strong oral and written communication skills.

• Excellent interpersonal abilities.

• High attention to detail and quality in documentation.

• Competent negotiation skills.

• Proficient computer skills with the capacity to learn relevant software.

• Good command of the English language and grammar.

• Basic knowledge of medical/therapeutic areas and medical terminology.

• Ability to work effectively in a team or independently under guidance as needed.

• Foundational organizational and planning skills.

• Basic understanding of applicable regional/national regulatory guidelines and EC regulations.

• A combination of appropriate education, training, and/or relevant experience may be considered as equivalent.

🏝️ Benefits

• Opportunities for collaboration and professional development.

• Work in a global team environment.

• Gain exposure to scientific innovation and excellence.