Country Approval Specialist

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

📋 Description

• Prepare, review, and coordinate local regulatory submissions in accordance with the global submission strategy.

• Offer local regulatory strategy guidance to internal clients with appropriate oversight.

• Provide and manage project-specific local SIA services.

• Reach out to investigators for activities related to submissions as necessary.

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

• Collaborate with internal functional departments to coordinate site start-up activities and submission schedules.

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

• Meet PPD target cycle times for sites.

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

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

• Assist with negotiations regarding grant budgets and payment schedules with sites.

• Support feasibility activities adhering to established timelines.

• Enter and maintain trial status information for SIA activities within PPD tracking databases.

• Prepare, establish, and manage local country study files and filing systems.

• Stay updated on PPD SOPs, client SOPs/directives, and current regulatory guidelines.

⛳️ Requirements

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

• A minimum of 2 years of prior experience providing the necessary knowledge, skills, and abilities for the position.

• Consideration may be given to equivalency through a combination of suitable education, training, and/or directly related experience.

• Proficient oral and written communication abilities.

• Exceptional interpersonal skills.

• Strong attention to detail and quality in documentation.

• Competent negotiation skills.

• Proficient computer skills and capacity to learn relevant software.

• Good command of the English language and grammar.

• Basic understanding of the medical/therapeutic area and medical terminology.

• Ability to function effectively in a team environment or independently, as directed.

• Basic organizational and planning capabilities.

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

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

• Ability to adhere to personal protective equipment requirements, including protective eyewear, garments, and gloves.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday-Friday work schedule.