Country Approval Associate

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

📋 Description

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

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

• 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 company target cycle times for site submissions.

• Contact investigators for activities related to submissions as necessary.

• Serve as a key country-level contact for ethical or regulatory submission activities.

• Work alongside start-up CRAs to prepare packages for regulatory compliance reviews.

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

• Assist with negotiations regarding grant budgets and payment schedules with sites.

• Enter and maintain trial status information in tracking databases.

• Prepare, set up, and maintain local country study files and filing processes.

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

⛳️ Requirements

• Bachelor's degree or an equivalent relevant academic/vocational qualification.

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

• Strong oral and written communication skills.

• Excellent interpersonal abilities.

• Keen attention to detail and quality in documentation.

• Proficient negotiation skills.

• Good computer proficiency with the capacity to learn necessary software.

• Competent English language skills and grammar.

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

• Capacity to work effectively in a team or independently, following direction as required.

• Basic organizational and planning abilities.

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

• Equivalency may include relevant education, training, and/or directly related experience.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and professional development.

• Exposure to scientific innovation and excellence.