**Role Summary** The Medical Compliance Manager is responsible for ensuring compliance with Amgen’s internal policies and external regulations in all China sponsorship programs, donation projects, and material reviews. This role emphasizes adherence to both global and local regulatory frameworks, safeguarding patient privacy, and ensuring the accurate and unbiased representation of healthcare professionals' (HCPs) scientific perspectives. The position also requires active participation in cross-functional collaborations, support for compliance initiatives, and readiness for audits and quality assurance processes. Key responsibilities also include review and approval of Amgen-owned and HCP-prepared materials to ensure scientific rigor, accuracy, and compliance with local prescribing information. This includes validating data, substantiating claims with credible references, and maintaining fair, balanced, and unbiased content. The role ensures materials are compliant, anonymized, and neutral, avoiding absolute claims, unsubstantiated comparisons, off-label content, and defamatory language, while prohibiting competitor mentions or disparagement and incorporating adverse event (AE) reporting reminders. Additionally, lecture slides and content developed by third-party institutions fall outside the review’s scope. **Responsibilities:** **Sponsorship Review and Donation Approval in C3 system** + Ensure all sponsorship programs and donation projects align with Amgen’s policies and regulatory requirements. + Act as the Medical representative for the China Funding Review Committee + Collaborate with internal teams, including but not limited to Legal, Compliance, Finance, IT Security, and Safety teams, to advance medical compliance initiatives and ensure organizational alignment. + Foster cross-functional partnerships to uphold compliance and ethical standards. **HCP self-prepared Material Review and Approve** + Ensure there are no absolute claims, guarantees about efficacy or safety, or unsubstantiated cross-study comparisons in materials, and ensure all materials include clear disclaimers to prevent any potential for misleading information. + Ensure material strict adherence to approved labels while avoiding off-label content, defamatory language, or unfair comparisons. + Ensure patient case-sharing materials are fully anonymized and devoid of identifiable information. + Ensure that materials incorporate appropriate disclaimers, avoid the use of product names, templates, or corporate branding, and maintain a neutral and compliant presentation style. + Ensure that competitive product companies and their product names are not mentioned, and avoid any attacks on competitive products. + Include reminders for reporting any detected adverse event (AE) cases. **Amgen owned material: Review and Approval** + Ensure that the medical data adequately supports the proposed claims, offering a strategic perspective grounded in sound medical evidence. + Verify that all data, statements, and figures presented are balanced, reflect fair and accurate medical opinions, and provide a comprehensive representation of the evidence. + Confirm that all data statements are scientifically rigorous, accurate, and up-to-date. Ensure they are substantiated by robust references and represent a fair and balanced view of the available data and literature. + Ensure all statements are appropriately extracted, accurately referenced, and backed by credible evidence. **Compliance with Local and Global Regulations** + Ensure all activities and processes comply with China’s Personal Information Protection Law (PIPL), Data Security Law (DSL), and related regulations. + Implement global and regional medical guidance and standard operating procedures (SOPs) within the affiliate. + Ensure compliance with intellectual property protection laws and regulations related to conflict-of-interest disclosures **Basic Qualifications** + Master’s degree or higher in Clinical Medicine, Pharmacology, or a related field. + Minimum of 5 years of experience in the pharmaceutical industry. + Learning agility and adaptability. + Excellent communication and presentation skills in both English and Mandarin. + Proven ability to build and maintain strong relationships internally and externally. + Strategic mindset with demonstrated business insights. **Preferred Qualifications** + Knowledge of global compliance standards (e.g., GCP, GLP, GRP, GVP) and Chinese regulations. + Previous experience in material approval processes or roles associated with medical compliance. + Strong project management skills, including planning, cross-functional coordination, and documentation. + Expertise in healthcare privacy laws and data security practices.