Country Approval Associate

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

📋 Description

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

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

• Collaborate with internal functional teams to synchronize site start-up and submission activities with established timelines and critical paths for site activation.

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

• Engage with investigators regarding activities related to submissions.

• Serve as the primary country-level contact for Ethical or Regulatory submission tasks.

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

• Contribute to the creation of country-specific Patient Information Sheets and Informed Consent forms.

• Aid in negotiating grant budgets and payment schedules with sites.

• Input and manage trial status data in company or client tracking databases.

• Prepare, organize, and maintain local country study files and filing procedures in line with relevant guidelines.

• Stay informed about PPD and client Standard Operating Procedures (SOPs)/directives and current regulations.

⛳️ Requirements

• Bachelor's degree or equivalent along with relevant formal academic or vocational qualifications.

• Prior experience ranging from 0 to 2 years that is comparable.

• 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 capacity to learn necessary software.

• Good proficiency in English language and grammar.

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

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

• Fundamental organizational and planning capabilities.

• Basic awareness of applicable regional/national regulatory guidelines and Ethics Committee (EC) regulations.

• Equivalency may be achieved through a combination of relevant education, training, and/or directly related experience.

• Capability to work in an office, laboratory, and/or clinical settings.

• Willingness to work with potential exposure to biological fluids, infectious agents, and electrical office equipment.

• Ability to utilize required personal protective equipment.

🏝️ Benefits

• Opportunities for collaboration and professional development.

• Experience within a global team environment.

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