Senior Director, European Compliance
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Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world’s most pressing infectious diseases. We have more than a decade of experience contending with some of the world’s most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.
Our scientists are committed to developing vaccine candidates for some of the world’s toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform. Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M™ adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.
Summary of the Position:
We are seeking a European Regional Compliance Officer to lead, drive, and manage all aspects of Novavax global compliance operations for Europe. Reporting directly to the VP, Global Compliance, this position will be responsible for developing strategic direction, compliance guidance, training, as well as implementing and maintaining all aspects of compliance in Europe. This position will serve as a critical and valued member of the Compliance and Legal team and will partner with other key stakeholders in the business by providing business-oriented and pragmatic guidance that enables the company to achieve its compliance obligations, purpose, and goals within Europe.
Responsibilities include but are not limited to:
- Provide strategic direction and compliance leadership to the region
- Actively participate and serve on regional leadership teams, providing compliance guidance consistent with the Company’s culture and values to promote ethical behavior, and enhance the Novavax global compliance program
- Develop compliance policies and procedures that integrate appropriate healthcare, corporate, privacy and other compliance controls to guide the company's operations
- Directs the execution of a training program through a matrix organizational structure across multiple departments for new and existing employees to ensure a thorough understanding and appreciation of the laws that impact the company's operations and how to conduct business practices appropriately
- Provide timely guidance and compliance oversight on company initiatives, such as training initiatives on applicable laws, regulations and NVX policies/procedures, FMV assessments, HCP consulting agreements, advisory boards, speaker programs, sponsorships, grants, and other initiatives involving interactions with healthcare professionals, healthcare organizations and patients/advocacy groups
- Identifies emerging industry and company trends to mitigate compliance risks through preparation and preemptive education
- Identify opportunities for growth and enhancement of the Novavax global compliance program
- Conduct periodic internal reviews, including risk assessment, monitoring, and auditing to support the annual Compliance Risk Assessment, create and implement a compliance action plan and annual monitoring program to ensure adherence to regulatory requirements and internal policies to mitigate risks where necessary
- Partner with internal (e.g., Legal, and Human Resources) and external (e.g., outside counsel or investigators) stakeholders for the conduct and resolution of potential compliance investigations, including the management of any resulting corrective actions plans
- Create and maintain dashboards or other reporting tools to track and assess compliance risks; prepare updates, presentations, and compliance reports for executive management, as necessary.
- May provide support on other policy and procedure implementation governing business operations
- In-depth understanding of the pharmaceutical industry with expertise in the body of laws, regulations, guidance, and codes impacting pharmaceutical companies, including knowledge of compliance issues related to the development and commercialization of branded pharmaceutical products
- Significant experience leading and implementing a global compliance program
- A successful track record building a culture of compliance and ethics in which compliance and business objectives are mutually reinforcing and establishing effective policies, processes, reporting, monitoring, and auditing programs
- Strong problem-solving and decision-making skills with demonstrated ability to think creatively and devise solutions to challenging problems
- Desire and ability to both develop strategy, make decisions and to implement timely, with hands-on creation and delivery of materials and processes
- Must have excellent analytical skills and comfort with multiple data sets, with the ability to draw conclusions and make informed decisions and recommendations
- Ability to clearly map process and data flows between systems
- A high sense of ethics and integrity with an approachable and pragmatic style to communication and application
- Able to build strong relationship with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo
- Strong sense of accountability and ownership; proactive and self-motivated
- Highly collaborative; ability to work independently and as a teammate; ability and desire to lead, influence and collaborate cross-functionally to build strong business relationships across the organization at all levels
- Thrive in a fast-paced, lean, highly dynamic environment
- Ability and willingness to travel
- BS/BA degree required
- Advanced degree (e.g., JD/MA/MS/MBA (from an ABA-accredited law school)) preferred
- Healthcare Compliance Certificate preferred
- Minimum of fifteen years of relevant experience in either legal or compliance roles within the pharmaceutical/biotech industry, including roles in leadership.
- Experience with vaccines or infectious disease
- Track record of effective leadership, management, and development of large, multi-disciplinary globally dispersed teams.
- Working cross-functionally, design and implement a global compliance program to ensure the company can effectively and efficiently fulfill its obligations within North America, specifically including US and Canada federal (Sunshine) and state disclosures and reporting requirements, including developing a regional strategy and roadmap, conducting evaluations and assessments, implementing processes and systems, record keeping, training and communications
- Timely and accurate submission of compliance reporting as needed, including the management and coordination with vendors, third parties and others to support the compliance program and its related activities
- Support the development of policies, processes and systems that accurately and efficiently identify, capture, and record interactions with healthcare professionals (master data) to enable, identify and track spend and other engagements
- Support both the Chief Compliance Officer and the VP, Global Compliance; develop reporting on the status of the corporate compliance and ethics program and risk management activities related to the NA Region and implement engaging compliance communications, trainings, and other content to support employees effectively and efficiently doing their jobs in a compliant and ethical way
- Support the development and implementation of controls and oversight for key areas of risk
- Support the development of a comprehensive compliance programs that defines, develops, and implements policies and processes to enable consistent, effective practices to minimize risk and ensure operational efficiency
- Other activities in support of the Legal, Regulatory and Compliance team, functional, and/or corporate strategies and goals
- Continuously seek out, and incorporate as appropriate, compliance related industry best practices and learnings
Every day our employees impact the future of health by preventing disease. To recognize their contributions, we offer them performance-based pay; a flexible, welcoming work environment; comprehensive and competitive benefits.
Novavax is headquartered in Gaithersburg, Maryland. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.
Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other protected characteristic.
Zurich, Zurich, CHE
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