Country Approval Associate

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

📋 Description

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

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

• Collaborate with internal functional departments regarding site start-up activities and submission timelines.

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

• Meet company target cycle times for sites.

• Contact investigators as necessary for submission-related tasks.

• Serve as the primary country-level contact for ethical or regulatory submission activities as required.

• Collaborate with start-up CRAs to develop regulatory compliance review packages.

• Aid in the creation of country-specific Patient Information Sheets and Informed Consent Forms.

• Support grant budgets and payment schedule negotiations with sites.

• Input and maintain trial status information in the company or client tracking databases.

• Prepare, organize, and manage local country study files and filing procedures.

• Stay updated on PPD and client SOPs/directives as well as current regulatory guidelines.

• Work in office, laboratory, and/or clinical settings with potential exposure to biological fluids, infectious organisms, and electrical office equipment.

⛳️ Requirements

• Bachelor’s degree or equivalent formal academic/vocational qualification.

• Relevant experience ranging from 0 to 2 years.

• Strong oral and written communication skills.

• Excellent interpersonal abilities.

• High attention to detail and quality documentation.

• Competent negotiation skills.

• Proficient computer skills with the ability to learn relevant software quickly.

• Good command of the English language and grammar.

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

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

• Basic organizational and planning skills.

• Fundamental knowledge of applicable regional/national regulatory guidelines and EC regulations.

• Consideration may be given to a combination of relevant education, training, and/or directly related experience as equivalency.

🏝️ Benefits

• Opportunities for collaboration and development.

• Exposure to a global team driven by passion, innovation, and scientific excellence.

• Personal protective equipment, including protective eyewear, garments, and gloves.