Country Approval Associate

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

📋 Description

• Prepare, review, and coordinate Country Submissions while adhering to the guidance and alignment with the global submission strategy.

• 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 consistent with the critical path for site activation.

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

• Contact investigators for activities related to submissions as necessary.

• Serve as the primary country-level contact for Ethical or Regulatory submission activities when required.

• Collaborate with start-up Clinical Research Associates (CRAs) to compile regulatory compliance review packages.

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

• Help negotiate grant budgets and payment schedules with sites.

• Enter and maintain trial status information within tracking databases.

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

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

⛳️ Requirements

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

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

• Strong oral and written communication skills.

• Excellent interpersonal abilities.

• High attention to detail and quality in documentation.

• Proficient negotiation skills.

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

• Good command of the English language and grammar.

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

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

• Fundamental organizational and planning abilities.

• Basic knowledge of applicable regional/national regulatory guidelines and Ethics Committee regulations.

• A combination of relevant education, training, and/or directly related experience may be considered as an equivalency.

🏝️ Benefits

• Opportunities for collaboration and professional development.

• Experience in a global team environment.

• Personal protective equipment provided/required for applicable working conditions.