Senior Manager - Commercial and Healthcare Compliance

BioNTech•Berkeley Heights, NJ

12d

About The Position

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 partnering with all aspects of the US business, providing compliance advisory support for local US teams, as needed. 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.

Requirements

Bachelor's degree required, 5 plus years of legal, compliance, audit, or commercial experience, of which 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, 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 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 and deliver on deadlines while managing multiple projects and priorities and ability to work with multiple systems, analytical tools, databases, and reporting platforms.
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

Responsibilities

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.
Providing 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).
Manage documentation requirements consistent with company requirements in relation to Team output (e.g., 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.
Creation and maintenance of presentations summarizing monitoring results to be delivered to the US Compliance Committee and serving as a business partner in support of the US business

Benefits

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