Principal Medical Writer

Overview BeOne continues to grow rapidly, offering challenging opportunities for experienced professionals who are highly motivated, collaborative, and passionate about fighting cancer. General Description As a key member of the regulatory writing team, you will develop high‑quality, fit‑for‑purpose clinical and regulatory documents—including protocols, investigator brochures, clinical study reports, regulatory briefing documents, and IND, NDA, BLA, and MAA modules—facilitating the timely submission and life‑cycle management of products in the BeiGene pipeline. You will also mentor junior medical writers (full‑time employees and/or contractors). Essential Functions Manage the production of regulatory documents and ensure compliance with guidelines, SOPs, templates, and style guides; handle multiple documents simultaneously, including complex or urgent projects. Lead document development strategy, collaborate with study and program teams, and act as filing or program lead on regulatory submissions. Identify and resolve risks and issues, manage timelines, and facilitate departmental and cross‑functional discussions. Optimize processes and tools, contribute to departmental and cross‑company improvements. Design and deliver training programs; provide technical and operational mentorship to junior writers. Share regulatory writing expertise within and across departments and with external communities. Education and Experience Advanced degree (MS, PhD, PharmD, MD) in life science, pharmacy, medicine, or health‑related science preferred. Bachelor’s degree with 5+ years of regulatory document writing or equivalent; MS with 4+ years; PhD/PharmD/MD with 2+ years. Computer Skills Technical expertise in Microsoft Word, Adobe Acrobat, electronic document management systems. Proficiency in Microsoft Outlook, Excel, and PowerPoint. Travel Occasional travel as needed. Global Competencies 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 Compensation and Benefits Salary Range: $119,300.00 – $159,300.00 annually. BeOne is committed to fair and equitable compensation. All employees are eligible for discretionary equity awards, the Employee Stock Purchase Plan, and a comprehensive benefits package that includes medical, dental, vision, 401(k), FSA/HSA, life insurance, paid time offs, and wellness programs. Non‑Commercial roles may receive an annual bonus; Commercial roles may receive an incentive compensation plan. EEO Statement BeOne is a proud equal‑opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other basis covered by applicable law. All employment is based on qualifications, merit, and business need. To ensure reasonable accommodation for individuals protected by Section 504 of the Rehabilitation Act, the Vietnam Era Veterans’ Readjustment Assistance Act, Title I of the Americans with Disabilities Act, and other laws, applicants who require accommodation may contact View email address on click.appcast.io. #J-18808-Ljbffr BeiGene, Ltd.