Country Approval Associate

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

📋 Description

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

• Assist in the preparation of submissions for the local Ministry of Health, as required.

• Work closely with internal departments to manage site start-up activities and submission schedules.

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

• Meet the company's target cycle times for site submissions.

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

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

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

• Assist in creating country-specific Patient Information Sheets and Informed Consent Forms.

• Support grant budgets and negotiate payment schedules with sites.

• Input and update trial status information in tracking databases.

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

• Stay informed about company and client SOPs, directives, and relevant regulatory guidelines.

⛳️ Requirements

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

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

• Strong oral and written communication abilities.

• Excellent interpersonal skills.

• High attention to detail and quality in documentation.

• Proficient negotiation skills.

• Competent computer skills and a willingness to learn relevant software.

• Proficient English language and grammar skills.

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

• Capability to work both independently and as part of a team, with appropriate direction.

• Fundamental organizational and planning abilities.

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

• Equivalent experience through relevant education, training, or directly related experience may fulfill role requirements.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and professional development.

• Exposure to scientific innovation and excellence.