Medical Compliance Manager

Role Summary

The Medical Compliance Manager is responsible for ensuring compliance with Amgen’s internal policies and external regulations in all China sponsorship programs, Grant and donation projects, Patient Program and publication process AUEG activities 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.

Responsibilities:

Activities include but not limited Sponsorship Review and Grant and Donation review and approval.

• 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.

Material Review and Approval

• Ensure materials are free from absolute claims, guarantees about efficacy or safety, unsubstantiated cross-study comparisons, and misleading information.
• Confirm all content strictly adheres to approved product labels, avoiding off-label content, defamatory language, or unfair comparisons.
• Ensure clinical cases materials are fully anonymized, with no identifiable information included.
• Include appropriate disclaimers and clear reminders for adverse event (AE) reporting.
• Ensure all data, claims, and statements are scientifically rigorous, up-to-date, and substantiated by credible, appropriately referenced sources.
• Provide strategic input to ensure content reflects fair, balanced medical perspectives and comprehensive interpretation of evidence.

Functional lead in local AUEG activities and Publication Process

• Ensure AUEG activities and publication fully compliance with GCP, GPP, GLP and other applicable regulatory and industry requirements
• Training, and checks to address issues, while providing strategic guidance on ensuring alignment with internal policies and external regulatory requirements.
• Ensuring alignment with global and local publication policies, overseeing the planning and execution process, and ensuring adherence to Amgen’s publication standards and process.

Comply with the Industry Code and relevant laws in pharmaceutical practice

• 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 is preferred.  Proven evidence on scientific publications, clinical practice and research is preferred. Minimum of 5 years of experience in the pharmaceutical industry which basic knowledge of drug discovery and development processes, business ethics and evidence-based medicine. 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, GPP, GLP, GRP, GVP) and Chinese regulations. GCP certifications are preferred.
• Previous publications in clinical journals or academic journals are preferred.
• 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.