Medical Compliance Manager - Remote

Overview

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.

In Short

• Ensure compliance with internal policies and external regulations.
• Act as the Medical representative for the China Funding Review Committee.
• Collaborate with internal teams to advance medical compliance initiatives.
• Ensure materials are free from misleading information and adhere to approved product labels.
• Lead local AUEG activities and Publication Process compliance.
• Implement global and regional medical guidance and SOPs.
• Comply with Chinese regulations regarding personal information protection.
• Provide strategic guidance on alignment with regulatory requirements.
• Build and maintain strong relationships internally and externally.
• Demonstrate strong project management skills.

Requirements

• Master’s degree or higher in Clinical Medicine preferred.
• Minimum of 5 years of experience in the pharmaceutical industry.
• Excellent communication skills in English and Mandarin.
• Knowledge of global compliance standards and Chinese regulations.
• Strong project management skills.
• Learning agility and adaptability.
• Proven ability to build relationships.
• Strategic mindset with business insights.
• GCP certifications preferred.
• Previous publications in clinical journals preferred.

Benefits

• Work with a leading biotechnology company.
• Opportunity to impact patient health outcomes.
• Innovative work environment.
• Collaboration with cross-functional teams.
• Professional development opportunities.