계약기간은 1년 계약 후 성과에 따라 최대 2년까지 근무 가능합니다.

Job Purpose

Manages all aspects of long-term and/or multi-center regulatory research projects, including planning, coordination, execution, outsourcing, and risk management, ensuring compliance with written standards, local legislation, licensing conditions, and regulatory requirements.

Key Responsibilities

Responsible for overseeing regulatory commitment studies, ensuring full compliance throughout the project lifecycle, including data collection, analysis, and report writing, in accordance with regulatory requirements.

Ability to develop and manage key study documents, ensuring alignment with scientific evidence and compliance with written standards and mandatory regulations.

Take business ownership of relevant vendors, conducting oversight and risk management in alignment with GSK’s Internal Control Framework (ICF).

Collaborate effectively with team members and key stakeholders to ensure successful project execution.

Perform any other assignments as directed

Requirements

BS in science or related field (Pharmacy, nursing, biology, epidemiology, life sciences)

6~8 years related experience (Study project management

Protocol, CRF, SAP development, CRO outsourced resource & contract management from vender assessment to execution, Budget projection & finance management, MFDS engagement, Hospital/clinical experience, Audit and clinical quality)

Experience working in the pharmaceutical industry, collaborating with operational teams to better understand requirements and applying solutions efficiently.

Maintain a high level of integrity while managing multiple priorities and responsibilities with a strong attention to detail and strategic organizational skills.

Focused on solution-oriented thinking, agile in adapting to new systems and processes, and motivated to work with new applications and business processes.

Demonstrate excellent verbal and written communication skills, with the ability to engage effectively with all levels both internally and externally, and the ability to write clear technical documentation required by regulatory agency (MFDS) in accordance with internal policies and national legislation.

Demonstrate a strong commitment to accuracy, quality, and meeting goals or deadlines, with a sense of urgency, flexibility, and accountability. Must be a committed active team player, prepared to work in and embrace a collaborative, team-based culture, while providing expertise to train site personnel.

Experience as the first author or co-author in research papers is highly valued. Include citation links to relevant publications in your CV

Native Korean/business level of English