[글로벌제약사] Post Marketing Surveillance Project Lead (정규직)

[담당업무]

·Leading and managing PMS/PASS projects end-to-end, from protocol outline through to study reporting, ensuring all timelines and deliverables are met
Ensuring strict compliance with Novo Nordisk policies, ICH-GCP/GPP, Helsinki Declaration, and all applicable Korean regulations
Monitoring recruitment status and project quality, taking proactive action to address deviations and conducting co-monitoring visits when needed. Managing project budgets effectively and maintaining comprehensive documentation in Trial Master Files and clinical trial management systems
Identifying, assessing and selecting appropriate sites for PMS/PASS projects in collaboration with your line manager and key stakeholders; Maintaining timely communication with Health Authorities and IRB/Ethics Committees, providing all required documentation and updates
Coordinating vendor relationships and CRO activities, ensuring quality oversight across all external partnerships

[근무부서 및 직급/직책]

근무부서: Medical Affairs
직급/직책: 팀원

[자격요건]

경력: 경력 7~16년
학력: 대졸
직무기술: PMS Project
기타:
Minimum Bachelor's degree in Medicine, Pharmacy, Nursing, Life Sciences or equivalent (preferred)
At least 7 years of working experience in PMS/PASS (minimum 5 years mandatory), with clinical trial experience as a CRA and project lead/manager preferred. ICH GCP training and certification (if applicable) will be added advantages.
Preferably 3 years of experience as a project lead in a global pharmaceutical company, with strong project management skills including vendor (CRO) management with strategic thinking capability
Excellent cross-functional communication skills to engage effectively with internal teams, external vendors, regulatory authorities and clinical sites
Fluency in written and spoken English and excellent IT skills including MS Office Package (Word, Excel and PowerPoint)
Good knowledge of ICH GCP/GPP and clinical research practices