Country Approval Associate

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

📋 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 aligned with the critical path for site activation.

• Meet company target cycle times for site submissions.

• Reach out to 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 CRAs to create regulatory compliance review packages.

• Help in developing country-specific Patient Information Sheets and Informed Consent forms.

• Assist in the negotiation of grant budgets and payment schedules with sites.

• Enter and maintain trial status information in tracking databases.

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

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

⛳️ Requirements

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

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

• Proficient oral and written communication skills.

• Strong interpersonal skills.

• Keen attention to detail and quality in documentation.

• Effective negotiation skills.

• Competent computer skills and the ability to learn the necessary software.

• Strong English language proficiency and grammar skills.

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

• Ability to collaborate in a team environment or work independently under direction as needed.

• Fundamental organizational and planning skills.

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

• Exposure to biological fluids with a potential risk of exposure to infectious organisms.

• Capability to utilize required personal protective equipment.

🏝️ Benefits

• Opportunities for collaboration and professional development.

• Work within a global team environment.

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