Senior Manager - Commercial and Healthcare Compliance

Senior Manager – Commercial and Healthcare Compliance

Location:

Berkeley Heights, NJ – United States (New Jersey). Full‑time.

Job

The Senior Manager, US Commercial & Healthcare Compliance role will play an instrumental part in the development and execution of the US Commercial Compliance Program in support of the US Commercial Team as BioNTech transforms from a primarily research and development organization into a commercial pharmaceutical company focused on oncology, infectious disease, and other severe diseases. This role will operationalize and manage monitoring, training, and data analytics initiatives designed to identify and mitigate risks.

Additionally, the role partners with all aspects of the US business, providing compliance advisory support for local US teams as needed. As the commercial strategy develops, the compliance approach evolves in response to emergent risks. The role participates in global initiatives that may impact the US market and works closely with the US Commercial & Healthcare Compliance lead to support the US Commercial Leadership Team and the broader US Leadership Team, including R&D, Manufacturing, Clinical Development, Human Resources, Finance, and IT.

• Execute and manage 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 upon internal requirements and/or external US laws, regulations, industry codes, and authoritative US agencies.
• Manage documentation requirements consistent with company requirements relating to monitoring results, risk assessments, delivered trainings, etc.
• Develop and implement US policies, guidelines, and/or procedures in support of US business.
• Develop and deliver training as gaps in understanding of key compliance principles are identified.
• Create and maintain presentations summarizing monitoring results for 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, at least 3 years in the healthcare, medical device, or pharmaceutical industries.
• Experience with laws, regulations, and industry guidance that affect the pharmaceutical industry, including OIG and PhRMA guidelines, False Claims Act, Anti‑Kickback Statute, the US Food, Drug, & Cosmetic Act, the Stark Law, and the US Federal Sentencing Guidelines.
• Experience executing compliance monitoring in the medical device or pharmaceutical industries.
• Solid understanding of compliance risks in the context of products governed by the US Food, Drug & Cosmetic Act.
• Experience interacting and collaborating with global colleagues.
• Ability to lead and facilitate discussions with senior leaders at the country and global levels.
• Ability to work independently, meet deadlines, manage multiple projects and priorities, and work with multiple systems, analytical tools, databases, and reporting platforms.
• Proven ability to collaborate with cross‑functional teams to identify needs, provide accurate compliance guidance, and communicate solutions. Proficient in Microsoft Office, Sharepoint, LMS, Concur, and other CRM systems used in the pharmaceutical sales environment.

$130,800 – $209,400 / year + benefits, annual bonus & equity (variable and dependent on performance).

• Medical, Dental and Vision Insurance
• Life, AD&D, Critical Illness Insurance
• Pre‑tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Virtual Tutoring & Childcare Membership (Sitter stream)
• Paid Time Off:
  Vacation, Sick, Bereavement, Holidays (including Floating) & Year‑End U.S. Shutdown
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance

Apply for our New Jersey, US location and simply send us your documents using our online form. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘Hire Right’.

You will be informed accordingly by your BioNTech recruiter.