Assistant Director, Healthcare Compliance & Privacy Programs
About The Position
Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals. At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees. With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive. We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career! ASSISTANT DIRECTOR, HEALTHCARE COMPLIANCE & PRIVACY PROGRAMS SUMMARY: Reporting to the Executive Director of Compliance, the Assistant Director, Healthcare Compliance & Privacy Programs helps advance and sustain Ionis’ healthcare compliance and privacy programs through cross-functional coordination and program support. This role partners with Compliance Counsel, Compliance Operations, and the Privacy Officer, to translate legal and regulatory requirements into practical processes, tools, training, and controls that enable consistent implementation of healthcare compliance, and data protection laws. This position works closely with business teams, including Legal, IT, Commercial, Medical Affairs, and R&D to foster a strong culture of ethics and compliance. This position may be remote or based in Carlsbad, CA or Boston, MA, with expectations for regular on-site engagement consistent with Ionis’ hybrid work philosophy.
Requirements
- Bachelor’s degree required; advanced degree or relevant certifications (e.g., CCEP, CIPM, CIPP, PMP) preferred.
- Minimum of 8 years of experience in healthcare compliance, privacy, or related roles within the pharmaceutical, biotechnology, or life sciences industry, or 6 years with an advanced degree or relevant certification/s
- Hands-on experience supporting data privacy programs, including DPIAs, RoPAs, data inventories, privacy risk assessments and data subject requests
- Working knowledge of Privacy Technology tools such as OneTrust
- Working knowledge of U.S. healthcare compliance laws and industry requirements, including, but not limited to, OIG and PhRMA guidelines, transparency reporting, Anti-Kickback Statute (AKS), False Claims Act (FCA), and related fraud and abuse laws
- Ability to translate legal and regulatory requirements into practical operational processes, tools, and controls
- Strong project and program management experience, with demonstrated ability to manage complex, cross-functional initiatives
- Strong organizational, analytical, and problem-solving skills
- Excellent written and verbal communication skills to clearly convey complex information to diverse audiences
- Familiarity with AI technologies and their application in compliance programs
- High level of integrity, discretion, and attention to detail in handling sensitive and confidential information
- Ability to work in a fast paced and dynamic work environment with a strong work ethic and positive attitude
- Agility to take on new projects and additional responsibilities, as required
- Occasional domestic travel (up to 20%)
Responsibilities
- Partner with healthcare compliance and privacy team leads with program planning, coordination, documentation, and continuous improvement initiatives, including compliance brand management
- Coordinate and support privacy program activities, including Data Protection Impact Assessments (DPIAs), Records of Processing Activities (RoPAs), data mapping, maintenance of related documentation, and facilitation of data subject requests
- Partner with Compliance attorneys to support investigations, issue escalation, and corrective action plans, as needed
- Prepare and present training and guidance materials for diverse audiences in support of Compliance attorneys and functional subject matter experts
- Coordinate training completion tracking, training record maintenance, and updates to training content
- Assist with the development, maintenance, and coordination of healthcare compliance and privacy policies and procedures
- Support healthcare compliance risk assessments, monitoring and audit activities and remediation efforts
- Conduct field monitoring activities, including field rides, attendance at promotional and educational events and congresses
- Healthcare compliance reviewer of HCP and Patient needs assessments and external funding requests
- Assist with healthcare compliance and privacy metrics and reporting for Compliance leadership
- Monitor changes in healthcare compliance and data protection requirements and assist in operationalizing program updates
- Support AI-related healthcare compliance and privacy initiatives
Benefits
- Ionis offers an excellent benefits package!
- Full Benefits Link: https://www.ionis.com/careers/working-at-ionis/#:~:text=our employee spotlight-,Benefits,-Employees are rewarded
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1,001-5,000 employees
