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 to local Ministry of Health, as necessary.

• Coordinate activities among internal functional departments and site start-up processes alongside submission activities and established timelines.

• Ensure that submission processes for sites and studies align with the critical path for site activation.

• Meet company target cycle times for site activations.

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

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

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

• Aid in the creation of country-specific Patient Information Sheets/Informed Consent documents.

• Support grant budget and payment schedule negotiations with sites.

• Enter and update trial status information in company or client tracking databases.

• Prepare, establish, and maintain local country study files and filing procedures.

• Stay informed about PPD and client SOPs/directives as well as current regulatory guidelines.

• Work in office, laboratory, and/or clinical settings while utilizing required personal protective equipment.

⛳️ Requirements

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

• Prior experience ranging from 0 to 2 years in a comparable role.

• Proficient oral and written communication skills.

• Strong interpersonal abilities.

• High attention to detail and quality in documentation.

• Effective negotiation skills.

• Proficient computer skills with the capacity to learn necessary software.

• Strong command of the English language and grammar.

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

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

• Fundamental organizational and planning capabilities.

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

• Ability to meet requirements through equivalent education, training, and/or directly related experience.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and professional development.

• Work environment focused on scientific excellence.