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 strategy and under guidance.

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

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

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

• Meet company target cycle times for sites.

• Reach out to investigators for submission-related tasks as required.

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

• Prepare regulatory compliance review packages alongside start-up CRAs.

• Create country-specific Patient Information Sheets and Informed Consent documents.

• Assist with negotiations related to grant budgets and site payment schedules.

• Enter and keep trial status information updated in tracking databases.

• Prepare, establish, and uphold 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 and relevant formal academic/vocational qualification.

• Prior experience of 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 and capability to learn necessary software.

• Proficient in English language and grammar.

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

• Ability to work collaboratively in a team or independently, as needed.

• Basic organizational and planning capabilities.

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

• Ability to work in an office/laboratory and/or clinical setting.

• Capability to work with potential exposure to biological fluids, infectious organisms, and electrical office equipment.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and development.

• Provision of personal protective equipment, including protective eyewear, garments, and gloves.