Country Approval Associate

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

📋 Description

• Prepare, review, and coordinate country and local EC submissions in accordance with global submission strategy and under appropriate guidance.

• Assist in the preparation of submissions to local Ministries of Health.

• Collaborate with internal functional teams regarding site start-up activities and submission deadlines.

• Ensure that submission processes are aligned with the critical path necessary for site activation.

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

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

• Serve as the primary country-level contact for ethical or regulatory submission activities as necessary.

• Collaborate with start-up CRAs to prepare packages for regulatory compliance reviews.

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

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

• Input and maintain trial status information in tracking databases.

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

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

⛳️ Requirements

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

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

• Strong oral and written communication skills.

• Excellent interpersonal abilities.

• Keen attention to detail and quality in documentation.

• Proficient negotiation skills.

• Competent computer skills with the ability to learn relevant software.

• Proficient English language and grammar skills.

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

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

• Foundational organizational and planning skills.

• Basic awareness of applicable regional/national country regulatory guidelines and EC regulations.

🏝️ Benefits

• Opportunities for collaboration and professional development.

• Reasonable accommodations available for individuals with disabilities.

• Additional benefits and privileges associated with employment.