New Jersey, US | full time | Job ID: 10592

Position Summary:

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, this role will be responsible for fostering a culture of ethics and compliance while partnering with all areas of the US Commercial business. It will work closely with and provide compliance advisory support to local US Commercial teams, including sales, commercial, medical, market access, and patient engagement teams. As the commercial strategy develops, so too will the compliance approach in response to the risks that will emerge and become evident. As part of the Global Ethics & Compliance Team, this role will also participate in global initiatives that may have an impact on the US market. This role will work closely with the US Commercial & Healthcare Compliance lead in their collective support of the US Commercial Leadership Team as well as the broader US Leadership Team which includes Research & Development, Manufacturing, Clinical Development, Human Resources, Finance and Information Technology teams.

Primary Responsibilities:

• Promote a culture of ethics & integrity across all business functions in the US.
• Providing risk-based, solutions-oriented and pragmatic compliance guidance based upon internal requirements and/or external US laws, regulations, industry codes, and accepted guidance from authoritative US agencies (i.e., Office of Inspector General of the US Department of Health and Human Services).
• Development and implementation of US guidance (e.g., policies, guidelines, manuals, etc.) in support of the US Commercial business.
• Development and execution of training in support of the US Commercial business.
• Establish and maintain strong cross-functional business partnerships with the US Commercial business and supporting functions (e.g., Legal, Finance, IT, HR, etc.) through the provision of impactful and informative compliance guidance.
• Execution of monitoring activities of US field teams (e.g., US MSLs, US Account Managers, US Field Sales), communication of results, development and execution of remediation plans, when necessary, and creation and maintenance of documentation.
• Lead the alignment of US monitoring efforts with the global monitoring efforts to ensure the avoidance of duplication.
• Participation and administration in key US committees chaired by the US Commercial Compliance Lead to take notes, capturing action plans for follow-up, calendar maintenance and meeting scheduling (e.g., US Compliance Committee and US Policy Governance Committee).
• Participation on the Global Ethics & Compliance Team initiatives, as may be requested from time to time.

Requirements:

• 5+ years of legal, compliance, audit, or commercial roles, of which at least 3 years specifically in the commercial biotech/pharmaceutical compliance role.
• Bachelor’s degree required.
• Experience with laws, regulations, and industry guidance that affect the pharmaceutical industry including, but not limited to, 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 biotech 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 and deliver on deadlines while managing multiple projects and priorities.
• Ability to work with multiple systems, analytical tools, databases, and reporting platforms.
• Understanding how to translate data into compliance insights that are actionable from a process improvement perspective.
• Proven ability to successfully collaborate with cross-functional teams to identify needs, provide sound and accurate compliance guidance and communicate solutions.
• Proficient in Microsoft Office applications, Sharepoint, LMS, Concur, and other CRM systems used in the pharmaceutical sales environment.
• Must be willing to be in the office in Berkeley Heights, NJ 2 – 3 days each week, and/or as needed.

Expected Pay Range: $130,800 - $209,400/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.

Your Benefits:

BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:

• 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
• Sitterstream: Virtual Tutoring & Childcare Membership
• 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

…and more! More details to be shared.

Berkeley Heights is New Jersey's growing hub within the life sciences industry and has already demonstrated the state’s commitment to innovation, collaboration, and excellence within the field. New Jersey's integrated approach to biotechnology and pharmaceuticals harmonizes academic rigor, industrial capability, and government support to create thriving conditions for a growing ecosystem. Cultivating an environment that seamlessly integrates cutting-edge research, robust manufacturing capabilities, and a dynamic business landscape, New Jersey has become a powerhouse in pharmaceuticals, biotechnology, and medical technology. As this region of New Jersey continues to develop, it stands ready to shape the future of medical science and technology, driving progress and improving health outcomes worldwide.

Apply now

• We look forward to your application!

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.