FSP 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 guidance.

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

• Collaborate with internal departments regarding site start-up activities and submission timelines.

• Ensure submission processes are aligned with essential paths for site activation.

• Meet company target cycle times for site activations.

• Reach out to investigators for activities related to submissions.

• Serve as the primary country-level contact for ethical and regulatory submission tasks.

• Work alongside start-up CRAs to prepare regulatory compliance review packages.

• Aid in the creation of country-specific Patient Information Sheets and Informed Consent Forms.

• Assist with negotiating grant budgets and payment schedules with sites.

• Input and maintain trial status information within tracking databases.

• Set up and manage local country study files and filing processes.

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

⛳️ Requirements

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

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

• Strong oral and written communication skills.

• Excellent interpersonal abilities.

• Keen attention to detail and quality of documentation.

• Proficient negotiation skills.

• Competent computer skills with a willingness to learn necessary software.

• Proficient English language skills and grammar.

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

• Capability to work effectively in both team settings and independently, as needed.

• Basic organizational and planning capabilities.

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

• Ability to operate within an office, laboratory, and/or clinical environment.

• Ability to utilize required personal protective equipment.

🏝️ Benefits

• Opportunities for collaboration and professional development.

• Experience working within a global team environment.

• Access to personal protective equipment such as protective eyewear, garments, and gloves.