Senior Manager, Healthcare Compliance

Role Summary

Senior Manager, Healthcare Compliance at Immunocore. Location: Conshohocken, PA and Gaithersburg, MD. Lead compliance operations within the biotech/pharma sector, partnering with internal and external stakeholders to ensure global regulatory compliance and to build a best-in-class program.

Responsibilities

• Develop and maintain trusted partnerships and effective lines of communication across multiple business units, including commercial and medical organizations.
• Serve as a dedicated business partner to the field, including senior leadership.
• Identify potential areas of compliance risk and develop plans to mitigate these risks.
• Stay abreast of regulatory changes, emerging trends, and industry best practices.
• Lead the collection, validation, and submission of transparency reports in accordance with US and International requirements.
• Support comprehensive audits of internal processes and practices and live monitoring of business activities to ensure compliance with relevant US healthcare laws and regulations.
• Monitor applicable and evolving regulatory requirements (e.g., OIG guidance, FCPA, GDPR, and state-specific laws) and assess their impact on business operations.
• Create and maintain compliance policies and procedures.
• Develop, implement, and manage compliance training programs for employees at all levels.
• Conduct regular training sessions and provide guidance on compliance-related topics.
• Monitor and track employee participation in training programs and ensure ongoing compliance education.
• Investigate, document and propose solutions for compliance issues and concerns, executing recommendations as appropriate.
• Assist investigations into potential compliance violations, implement corrective action plans, and ensure proper documentation and reporting.
• Prepare and present compliance updates for Corporate Compliance Committee / senior leadership.
• Lead Ad Hoc compliance projects.

Qualifications

• Essential: Bachelor's degree; 5‚Äì7+ years of related experience, ideally in Biotech or Pharma; at least 3 years in health care compliance/privacy.
• Preferred: Certification in healthcare compliance (e.g., CHC, CCEP).

Skills

• Ability to develop trusted partnerships and maintain effective communication across functional units, including commercial and medical organizations.
• Ability to conduct live trainings for various team members.
• Knowledge of healthcare privacy laws and obligations (US state and federal laws, HIPAA, GDPR, etc.).
• Knowledge of healthcare laws and regulations (False Claims Act, Anti-Kickback Statute, Sunshine Act, US State Transparency Laws, FDCA, FCPA/UKBA, etc.).
• Excellent analytical, organizational, and communication skills; ability to work independently and in a team; strong presentation skills.

Education

• Bachelor's degree; relevant advanced certifications are a plus.

Additional Requirements

• Travel: 25-35% (Domestic or International).
• Office environment with standard equipment; compliance with professional standards.