Imagine… 2 weeks after the birth of your child you realize they aren’t meeting critical developmental milestones and after months of doctor’s appointments you are told your baby has a rare neurological disease that would impact how they would live their lives. This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it’s the reason why we at Novartis Gene Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

Novartis Gene Therapies (GTx) seeks a compliance professional to lead the Company’s compliance programs and provide day-to-day support to cross-functional teams on various compliance matters, with a focus on transparency reporting, FDA promotional matters, charitable spending, training/policy management, privacy, and anti-kickback, including alignment to parent company policies.

• In close collaboration with US Novartis Pharmaceuticals Corporation, support the coordination and execution of Corporate Integrity Agreement related activities including but not limited to harmonization of compliance programs across GTx, and manage ongoing implementation and operational requirements.
• Manage implementation of processes to collect and analyze aggregate spend data from multiple functions for compliance with federal Sunshine Act reporting requirements.
• Manage state-law reporting obligations, including price transparency.
• Support global teams on regulatory matters affecting compliance, such as the global managed access program and clinical studies.
• Monitor and support charitable spending processes to ensure compliance with anti-kickback requirements for donations, patient assistance program, research collaborations, independent medical grants, funding for advocacy groups, and educational grants.
• Develop and deliver compliance training to relevant stakeholders to ensure understanding of relevant policies and procedures as well as compliance with applicable laws and regulations.
• Manage and implement training programs, tracking, and certification of records for compliance curricula.
• Responsible for analyzing, measuring, and evaluating training programs for effectiveness and ensuring they are meeting training objectives.
• Maintain compliance policies and manage the implementation of parent company policies.
• Collaborate with other departments of the company in addressing their policies, such as pharmacovigilance and clinical operations processes that overlap with Ethics, Risk & Compliance.
• Interface with global Ethics, Risk & Compliance colleagues on policy development and alignment.
• Lead and provide support to compliance initiatives to comply with privacy rules.
• Collaborate with global partners (GTx EMEA and Novartis Ethics, Risk & Compliance teams) and external advisors to support non-US policies (e.g., EFPIA, GDPR).
• In coordination with EMEA legal, develop solutions to manage data flows from EU/US and other regions.
• Provide general project management leadership for the Ethics, Risk & Compliance function.
• Create, track and monitor appropriate metrics for Ethics, Risk & Compliance department.
• Contribute to other projects that address emerging needs as required.

• Bachelor’s Degree required (life sciences, public policy, marketing, business, or related discipline preferred).
• Advanced degree desirable (PharmD, PhD, MS, MPH, MBA or similar degree in life sciences, public policy, regulatory, or related discipline, with more than one degree preferred).
• 10 years of experience in the healthcare legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry (anti-kickback, government fraud and abuse, FDA off-label promotion, PhRMA Code, HIPAA, etc.).
• Strong preference for an individual with institutional knowledge of Novartis compliance policies and practices.

Vaccine Policy:

While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com.