Project Manager, Medical Affairs PMO, South Korea

About us BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeOne , please visit www.beonemedicines.com and follow us on LinkedIn and X (formerly known as Twitter). BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. Job Description: General Description: Project Manager, Medical Affairs Program Management Office (PMO), South Korea, serves as the country-level program management and governance for Korea Medical Affairs. The position connects medical strategy with structured, compliant, and measurable execution across the Country Medical Plan, evidence-generation programs, departmental initiatives, budgets, vendors, and operational processes. This position supports BeOne Medicines medical assets through the successful execution of Medical Affairs programs and deliverables in partnership with internal functions, global and regional teams, external vendors, academic investigators, healthcare institutions, and collaboration partners. The position reports to the Sr. Medical Operation manager, Medical Affairs Program Management Office. The role retains operational accountability for local evidence-generation including post-marketing study (PMS) and real-world evidence/real-world data (RWE/RWD) studies required or undertaken as post-regulatory or post-reimbursement commitments, investigator-initiated trials (IITs), Early-Access programs (EAPs). Essential Functions of the job: 1 . Local Evidence Generation and Program Operations 1 .1 Post-Marketing Study and Other Phase IV Studies Support the development, review, and approval coordination of study concepts, synopses, protocols, informed consent forms, safety management plans in collaboration with the medical responsible person and relevant functions and lead the development of case report forms, project management and other essential documents. Lead CRO and other related vendor selection, quality review, contracting, study start-up, timeline planning, budget oversight, scope-change management, and operational risk management. Serve as the primary operational contact for the Contract Research Organization (CRO) and oversee performance against contracted deliverables and key performance indicators, including site activation, enrollment, data milestones, reports, and close-out. Coordinate with Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance, Procurement, Finance, global Medical Operations, and other relevant teams to support compliant execution and required submissions. Coordinate the review and approval of PMS result reports, safety reports, and related supporting documents, and provide finalized documents to the local safety responsible person in a timely manner to support required submissions to the Ministry of Food and Drug Safety within applicable timelines. 1 .2 Real-World Evidence and Real-World Data Studies under Regulatory requirements Lead or support the planning, execution, and oversight of RWE/RWD studies in Korea conducted to fulfill post-approval, risk-management, reimbursement, payer, or other health-authority requirements or commitments, with a primary focus on regulatory or access-driven evidence-generation needs. Exploratory or scientific-interest driven RWE/RWD activities that are not directly linked to regulatory, payer reporting/submission obligations are excluded from the primary scope of this role. Provide operational and strategic input for observational studies, registries, database studies, chart reviews, and other fit-for-purpose real-world evidence approaches. Coordinate feasibility, data-source and vendor assessment, study planning, contracting, budget management, timelines, deliverables, data quality, privacy considerations, and operational risk management across the study lifecycle. Collaborate with Medical Affairs, Epidemiology, Biostatistics, Health Economics and Outcomes Research, Regulatory Affairs, Pharmacovigilance, Legal, Compliance, Data Privacy, Quality Assurance, and external stakeholders, as applicable. Ensure that RWE/RWD activities are conducted in accordance with approved protocols, applicable Korean requirements, relevant scientific and industry guidelines, data privacy requirements, and internal procedures. Coordinate RWE/RWD-related communications, document packages, and responses to follow-up requests from regulatory agencies, payers, or other health authorities in collaboration with Medical Affairs, Regulatory Affairs, Market Access, Pharmacovigilance, Legal, Compliance, and relevant external partners. Support the completion and submission readiness of study outputs, including final study reports, regulatory or reimbursement submission materials, responses to additional health-authority requirements, publications, congress presentations, and other approved communication channels, as applicable. 1 . 3 Early Access Program Incl. Compassionate Use/Pre-Reimbursement Access Programs Develop country CUP and/or PRAP plans in alignment with global program teams and Korean requirements in collaboration with the Medical Director and/or TA Lead. Support the development of local essential documents, including protocols, informed consent forms, patient information, operational plans, and required submission materials. Lead and execute local start-up activities in collaboration with the medical responsible person, including site selection, institutional review board submission, contracting, investigational product shipment coordination, and readiness activities. Manage program and site activities to support timely and compliant delivery, excluding site monitoring or other on-site activities unless separately assigned and approved. Prepare or coordinate final report submissions to the Ministry of Food and Drug Safety in collaboration with the medical person responsible and Regulatory Affairs. For single-patient use requests, lead the operational process in accordance with local requirements in collaboration with the medical person responsible. Collaborate with local Medical Affairs, Pharmacovigilance, Regulatory Affairs, Supply Chain M