Senior Study Start Up Associate – Regulatory Affairs

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

📋 Description

• Perform feasibility evaluations, identify suitable sites, negotiate site contracts, and execute other essential SSU tasks.

• Offer specialized knowledge to Study Start Up team leaders and project teams, providing critical insights to enhance success.

• Prepare and manage submissions to regulatory, ethics, and other pertinent organizations, ensuring adherence to all applicable regulations and guidelines.

• Assist in the creation, finalization, and assessment of Master and Country Specific Subject Information Sheets/Informed Consent Forms, upholding the highest standards of patient safety and informed consent.

⛳️ Requirements

• A Bachelor's degree or equivalent local qualification and/or relevant experience in the Medical/science field and/or discipline.

• A minimum of 3 years of experience or familiarity with clinical study start-up requirements and activities.

• Proficiency in the local language and English is mandatory.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.