Henlius Compliance Senior Manager -BP
Responsibilities:
1. Compliance Management
Proactively implement and execute compliance programs across the organization.
Proactively understand evolving compliance requirements to pre-emptively address and mitigate compliance risks.
Perform other assignments as requested by the line manager.
2. Compliance Business Partnering
Provide day-to-day compliance support and advice to internal business partners across commercial and medical functions.
Evaluate all business and commercial activities requiring compliance pre-approval prior to execution and payment, ensuring process transparency, documentation completeness, and proper archiving.
Review commercial and medical projects through thorough analysis and provide appropriate compliance guidance and risk mitigation strategies to business partners.
Draft, implement, and maintain up-to-date compliance handbooks, policies, procedures, and guidance to address the evolving needs of the business unit.
3. HCP Interactions & Governance
Oversee and govern all interactions with Healthcare Professionals (HCPs) and Healthcare Organizations (HCOs), including advisory boards, speaker programs, consultancies, congress sponsorships, and educational grants.
Ensure all HCP engagements adhere to Fair Market Value (FMV) standards, HCP tiering frameworks, and established expense limits for travel, accommodation, and hospitality.
Review and approve HCP contracts, Fee-for-Service (FFS) arrangements, and preclearance requests in alignment with company policies and applicable healthcare compliance laws.
Collaborate with the Medical Department to establish and maintain compliance rules for Investigator-Initiated Trials/Studies (IIT/IIS) and other medical-led initiatives.
Qualifications
Strong executive presence, integrity, and work ethic.
Minimum 7 years of compliance BP experience in the healthcare/pharmaceutical industry (Required).
Good understanding of Patient Assistance Programs (PAP), patient enrollment projects, and Medical-led initiatives (IIT/IIS) is a strong plus.
Excellent technical compliance skills, business acumen, and analytical/strategic capabilities.
Proven ability to collaborate with senior management on challenging and complex compliance matters.
Fluency in both Mandarin and English.
Experience in a Big 4 or Legal background is a plus.