FSP 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.

• Coordinate with internal functional departments and manage site start-up activities according to submission timelines.

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

• Meet company target cycle times for site activations.

• Reach out to investigators for any submission-related activities as necessary.

• Serve as the key country-level contact for ethical or regulatory submission tasks.

• Prepare regulatory compliance review packages in collaboration with start-up CRAs.

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

• Provide assistance with grant budget preparation and payment schedule negotiations with sites.

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

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

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

⛳️ Requirements

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

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

• Strong oral and written communication abilities.

• Excellent interpersonal skills.

• Keen attention to detail and quality in documentation.

• Proficient negotiation skills.

• Competent computer skills and a capacity to learn necessary software.

• Proficient English language and grammar skills.

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

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

• Fundamental organizational and planning skills.

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

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

• Ability to utilize necessary personal protective equipment.

🏝️ Benefits

• Opportunities for collaboration and professional development.

• Work within a global team environment.

• Gain exposure to innovation and scientific excellence.