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 pl