Senior Manager - Commercial and Healthcare Compliance

Role Summary

The Senior Manager, US Commercial & Healthcare Compliance will help develop and execute the US Commercial Compliance Program in support of the US Commercial Team as BioNTech transitions from primarily a research and development organization to a commercial pharmaceutical company. The role will manage monitoring, training, and data analytics initiatives to identify and mitigate risks, and provide compliance advisory support to local US teams.

It will collaborate with global initiatives and work closely with the US Commercial Leadership Team and broader US Leadership Team, including R&D, Manufacturing, Clinical Development, Human Resources, Finance, and Information Technology.

• Execute and manage the daily risk assessment, monitoring and training initiatives to ensure compliance with BioNTech company guidance.
• Communicate, prioritize and manage action plans driven by monitoring results, compliance risk assessments, and recommendations.
• Provide compliance guidance based on internal requirements and/or external US laws, regulations, industry codes, and guidance from authoritative US agencies (e.g., Office of Inspector General of the US Department of Health and Human Services).
• Manage documentation requirements consistent with company requirements in relation to team outputs (e.g., monitoring results, risk assessments, delivered trainings).
• Develop and implement US policies, guidelines, and/or procedures to support the US business.
• Develop and deliver training as gaps in understanding of key compliance principles are identified.
• Create and maintain presentations summarizing monitoring results to be delivered to the US Compliance Committee and serve as a business partner in support of the US business.

• Bachelor’s degree required, 5+ years of legal, compliance, audit, or commercial experience, including at least 3 years in the healthcare, medical device, or pharmaceutical industries.
• Experience with laws, regulations, and industry guidance affecting the pharmaceutical industry, including OIG/PhRMA guidelines, False Claims Act, Anti-Kickback Statute, FDA Act, Stark Law, and US Federal Sentencing Guidelines.
• Experience executing compliance monitoring in the medical device or pharmaceutical industries.
• Strong understanding of compliance risks in the context of products governed by the FDA.
• Experience interacting and collaborating with global colleagues.
• Ability to lead and facilitate discussions with senior leaders at country and global levels.
• Ability to work independently and deliver on deadlines while managing multiple projects and priorities; proficiency with multiple systems, analytical tools, databases, and reporting platforms.
• Proven ability to collaborate with cross-functional teams to identify needs, provide sound compliance guidance, and communicate solutions. Proficiency in Microsoft Office, SharePoint, LMS, Concur, and other CRM systems used in the pharmaceutical sales environment.