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Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is currently conducting multiple late-stage clinical trials for NVX-CoV2373, our vaccine candidate against the virus that causes COVID-19, and has recently reported exciting and highly encouraging initial efficacy results. NanoFlu, our quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines. Our proprietary technology platform leverages the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.
Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.
We are seeking a Senior Director, Compliance Operations, who 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 contributions that enable the company to achieve its compliance obligations, purpose, and goals.Responsibilities include but are not limited to:
- Develop company-wide compliance policies and procedures that integrate appropriate healthcare, corporate, privacy and other compliance controls to guide the company's operations
- Develop and monitor the execution of a training program 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
- Provides legal support for the company's expanding international operations, proactively identify legal and regulatory issues, and collaborate cross-functionally to offer creative solutions to mitigate risks
- Provide timely guidance and compliance oversight on company initiatives, such as 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
- Conduct periodic internal reviews, risk assessments, monitoring and auditing to ensure that compliance policies and procedures function as intended and the company identifies potential compliance risks and remediates 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
- Advanced degree (e.g., JD/MA/MS/MBA (from an ABA-accredited law school)) and/or healthcare compliance certification preferred, and a minimum of ten years of relevant experience in both developing (e.g., strategy, materials, system identification) and then implementing legal or compliance programs in the pharmaceutical/biotech industry, including roles in leadership
- 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
- 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
- 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
- Thrive in a fast-paced, lean, highly dynamic environment
- Ability and willingness to travel
- Working cross-functionally, design and implement a global compliance program to ensure the company can effectively and efficiently fulfill its obligations across the globe, specifically including Country and US federal (Sunshine) and state disclosures and reporting requirements, including developing a global strategy and roadmap, conducting evaluations and assessments, policy development, 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 the Chief Compliance Officer and the Compliance Committee; develop reporting on the status of the corporate compliance and ethics program and risk management activities to the Compliance Committee, Executive Team and/or the Board of Directors develop 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 and Compliance team, functional, and/or corporate strategies and goals
- Continuously seek out, and incorporate as appropriate, compliance related industry best practices and learnings