Project Manager - Medical Affairs PMO

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 Management, Quality Assurance, and relevant global teams.

1.4 Investigator-Initiated Trials

• Collaborate with the global IIT team, local field medical team, and relevant functions from a country medical perspective to support local IIT project planning, governance alignment, and execution readiness in accordance with applicable global processes and Korean health authority requirements.

• Provide country-level operational input into IIT planning to ensure Korean regulatory and local-practice requirements are reflected, including feasibility considerations, timelines, budgets, contracting, documentation, required approvals, and operational risk management.

• Establish or provide local tools, trackers, and governance support for internal review, approval, contracting, milestone and payment tracking, study-status visibility, and document archiving in accordance with country regulations and company procedures.

• Provide non-promotional operational support, communication frameworks, and practical tools to facilitate effective coordination among internal stakeholders, site staff, and principal investigators while maintaining investigator independence, Field Medical responsibilities, and applicable governance requirements.

• Support country-level IIT governance by monitoring progress directly or through agreed tracking tools, identifying operational issues, facilitating resolution with appropriate stakeholders, and escalating material risks or delays to the relevant governance body.

2. Local Compliance, Quality, and Document Governance

• Ensure that Medical Affairs programs are executed in accordance with applicable Korean laws and regulations, industry codes, data privacy requirements, company policies, standard operating procedures, approved plans, and contractual obligations.

• Maintain complete, accurate, current, and inspection-ready program documentation in appropriate validated or access-controlled repositories, as applicable.

• Manage SharePoint or other approved repositories for project plans, approvals, contracts, invoices, meeting records, trackers, dashboards, final reports, and deliverables.

• Coordinate required internal reviews and approvals, and maintain traceable documentation of decisions, actions, deviations, risks, and issue resolution.

• Support audits, inspections, quality reviews, and compliance reporting, as applicable.

• Promote consistent document naming, version control, access management, retention, and archival practices across Korea Medical Affairs programs.

3. Budget and Spending Management

• Track project budgets, purchase orders, invoices, milestone payments, scope changes, and financial risks; investigate variances and coordinate timely resolution with Finance and relevant budget owners.

• Maintain visibility into planned, committed, invoiced, accrued, and actual spend across Medical Affairs programs and cost categories.

• Provide regular budget and spending reports to support prioritization, resource planning, and leadership decision-making.

• Support annual operating plan activities, periodic forecast updates, accrual exercises, and other corporate finance requirements applicable to Korea Medical Affairs.

4. Vendor, Contract, and Procurement Execution

• Lead or coordinate vendor identification, request-for-proposal activities, bid evaluation, vendor selection, qualification, contracting, and onboarding for Medical Affairs programs.

• Collaborate with Procurement, Legal, Compliance, Quality Assurance, Finance, and business owners to ensure contracts, statements of work, budgets, purchase orders, and required approvals are completed before work begins.

• Manage vendor performance against contracted scope, timelines, deliverables, quality expectations, key performance indicators, and budgets.

• Coordinate change orders and scope changes, assess operational and financial impact, and ensure appropriate documentation and approval.

• Resolve sourcing, contracting, vendor, and project delivery issues and drive timely resolution or escalation as appropriate.

• Support vendor registration, contract approval requests, procurement and SAP processing, invoice review, and related administrative requirements as needed.

5. PMO Governance and Department Initiatives

• Facilitate alignment and effective communication across Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance, Supply Chain, Finance, Procurement, Legal, Compliance, Biostatistics, Epidemiology, and relevant global or regional teams.

• Identify opportunities to simplify processes, improve operational efficiency, share best practices, and standardize project management approaches and performance measures within Korea Medical Affairs.

• Lead or contribute to departmental and organizational initiatives, new operating-model solutions, and other special projects assigned by the Country Medical Director.

• Establish scalable tools, templates, trackers, dashboards, and meeting frameworks that improve transparency, accountability, and collaboration.

• Identify recurring gaps, propose solutions, and use data and operational insights to support change management and adoption.

Qualification Required:

Required Education/Experience:

• Bachelor’s degree in life sciences, R.N. or equivalent with significant experience in healthcare industry with strong clinical and medical, research background is essential.

• Minimum of 7 years of experience in the pharmaceutical or biotechnology industry, including substantial project/program management experience.

• Knowledge of relevant regulatory and compliance requirements.

Computer Skills: Excellent proficiency in Microsoft Office including Excel, PowerPoint, and Word.

Other Qualifications: Not applicable.

Travel: Extensive domestic, regional, and international travel may be required.

What We Offer To Our Valued Employees

• Market competitive compensation package including performance-based annual bonus scheme

• Company shares (generous welcome grant!)

• In-house and external learning and development opportunities

• Fantastic benefits program and keep improving!

• Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.

• Join us and Make momentum in your career!

BeOne Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork

• Provides and Solicits Honest and Actionable Feedback

• Self-Awareness

• Acts Inclusively

• Demonstrates Initiative

• Entrepreneurial Mindset

• Continuous Learning

• Embraces Change

• Results-Oriented

• Analytical Thinking/Data Analysis

• Financial Excellence

• Communicates with Clarity

BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.

Due to BeOne’s global operation, job applicants’ data will be stored in Workday (currently located in the U.S.). Besides, job applicants’ data will be kept for one year to facilitate potential application for other suitable positions in BeOne. For further details, please refer to BeOne’s Job Applicant Privacy Policy (https://beonemedicines.com/privacy-policy).

If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms.

If you have any concern, please DO NOT provide any resume or other personal information to us.