Country Approval Associate

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

📋 Description

• Prepare, review, and coordinate country and local EC submissions in accordance with global submission strategy and under guidance.

• Support the preparation of local Ministry of Health submissions, as necessary.

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

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

• Meet the company's target cycle times for sites.

• Communicate with investigators concerning submission-related activities as required.

• Serve as a key contact at the country level for ethical or regulatory submission activities as needed.

• Assist start-up CRAs in preparing regulatory compliance review packages.

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

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

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

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

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

⛳️ Requirements

• Bachelor's degree or equivalent with relevant formal academic or vocational qualifications.

• Previous experience ranging from 0 to 2 years is preferable.

• Strong oral and written communication abilities.

• Excellent interpersonal skills.

• Keen attention to detail and quality in documentation.

• Proficient negotiation skills.

• Competent computer skills and the ability to learn necessary software.

• Strong English language proficiency and grammar skills.

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

• Capability to work effectively in a team setting or independently, as required.

• Basic organizational and planning skills.

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

• Equivalency through a combination of education, training, and/or directly related experience may be considered.

• Ability to work in office, laboratory, and/or clinical environments.

• Proficient in using required personal protective equipment.

🏝️ Benefits

• Opportunities for collaboration and professional development.

• A global team environment.

• Exposure to scientific excellence and innovation.