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Executive Director Healthcare & Commercial Compliance

 

Join our team of pioneers!

Based in Cambridge, MA and Gaithersburg, MD. We are committed to improving the health of people worldwide with our fundamental research and our work in the area of development of immunotherapies utilizing the full potential of the immune system to fight cancer, infectious diseases and other serious diseases. We believe in scientific rigor, innovation and passion as driving forces. BioNTech was founded by scientists and physicians to translate science into survival by combining fundamental research and operational excellence.

With decades of deep immunology expertise and experience in developing and optimizing mRNA as part of its broad suite of novel technologies, the company is working with the global community to defeat life-threatening and serious diseases such as cancer, COVID-19, malaria and tuberculosis. The first ever approved mRNA vaccine was created in the labs of BioNTech in Mainz, Germany. A fully integrated immunotherapy powerhouse. We remain focused on bringing our broad pipeline of next-generation immunotherapies and vaccines to people around the world to address cancer, infectious diseases, as well as a growing list of other medical conditions. To accomplish this, we continue to be deeply rooted in science and academic research while also having built a fully integrated, global immunotherapy company with cGMP and GMP manufacturing facilities anchored around deep expertise in immunology and complemented by an expanding set of capabilities.
 

 

Executive Director Healthcare & Commercial Compliance

 

The BioNTech Compliance & Business Ethics department is expanding to meet the needs of the increasing international and global growth of the Company. As we strive to bring products to the US market by 2026, we now seek to expand our U.S. Commercial and Healthcare Compliance program.  We want to ensure that the Company has a robust Compliance program, including well trained medical science liaisons and sales representatives as well as sound compliance related processes. Join an international team of highly motivated Compliance representatives that is open minded, friendly, ethically and compliance-oriented striving to add value to BioNTech. Position will be located in our New Jersey office. 

 

Primary Responsibilities

  •  Create and implement specific healthcare compliance policies, related SOPs, processes and guidance materials required for U.S. product launch

  • Set up and execute training program for MSLs, sales representatives and other members of the commercial organization to include training on False Claims Act, Anti-Kick Back, PhRMA Code, FCPA, HIPAA

  • Assist in the creation of an efficient MLR process together with relevant stakeholders.

  • Collaborate with cross-functional stakeholders on the creation of required compliance processes relating to such matters as contracting with HCP, market research, grants, IISs, advisory boards and speaker programs

  • Assist in development and oversight of transparency reporting and take-back program

  • Assist in the development of process to comply with the FCPA and provide oversight of FCPA compliance

  • Provide updates to the Global Head of Commercial/Healthcare Compliance as well as local management regarding compliance matters

  • Collaborate with local management to provide meaningful and prompt guidance on day – to -day matters pertaining to potential compliance risks providing a balanced risk based approach

  • Assist in monitoring, auditing and investigations with respect to the healthcare compliance program

 

 


Requirements: 

 

Bachelor's degree 

The ideal candidate:

 

•   is experienced. You have a deep U.S. commercial compliance experience and experience of building local compliance programs within a global pharmaceutical organization (12 plus years). You strive to build a robust and integrated local U.S. compliance program that fosters an ownership mindset at every level.

•   is strategic. You can effectively balance global strategy with local execution, ensuring that local compliance priorities align with business needs. You adept at transitioning between strategic vision and effective execution of operational tasks.

•   is agile. You are capable of evaluating multiple strategies to enhance local compliance programs and adept at making decisions that balance immediate needs with long term objectives. You are capable of adjusting local compliance strategies in response to regulatory changes and market trends at both global and local levels.

•   is a proactive business partner. You excel in compliance advisory: You are capable of delivering timely, thorough and firm position on compliance matters to key stakeholders, including the U.S. commercial leadership team. You recognize that proactive compliance measures are essential for preventing future issues. You proactively drive innovation in ethics and compliance practices to better serve the businesses.

•   is an excellent communicator. You have good interpersonal skills to influence desired outcomes. You have the ability to manage multiple matters simultaneously and  to respond fast, clearly and pragmatically to urgent situations. 

 

Preferred Requirements:

  • Robust project management skills

  • International/global work experience

  • Compliance experience in the oncology field



Benefits for you:
 

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.


 

BioNTech is an equal opportunity employer and complies with all applicable federal, state, and local fair employment practices laws. BioNTech does not tolerate discrimination against employees or applicants because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including gender, pregnancy, sexual orientation, and gender identity), age, physical or mental disability, citizenship, past, current, or prospective service in the uniformed services, genetic information, or any other characteristic protected under applicable federal, state, or local law.

If you are unable or limited in your ability to use or access BioNTech’s online application tools due to a disability, you can request reasonable accommodations by calling 1-857-228-6231or by e-mailing jobs@biontech.de. Thank you for your interest in BioNTech.

 

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