Associate Director, Compliance Monitoring and Operations
4 Days Old
Associate Director, Compliance Monitoring And Operations 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!
Associate Director, Compliance Monitoring And Operations
Summary:
The Associate Director, Compliance Monitoring and Operations, supports the Head of Compliance Operations by managing and executing Ionis' Healthcare Compliance Risk Assessment and Monitoring programs. The role is flexible to both on site (CA or Boston office) and remote placement. This role focuses heavily on leveraging data analytics to provide actionable insights into compliance risks and supports compliance operations broadly, including transparency reporting, HCP engagements, policy and training, program development and process improvements. The position works closely with cross-functional teams including Commercial, Finance, Medical, IT, HR, and R&D to foster a strong culture of ethics and compliance.
Responsibilities:
Support the management and execution of Ionis' risk-based Healthcare Compliance Monitoring Program, including planning and execution of live and virtual monitoring activities and transactional/desktop monitoring
Support and execute the annual U.S. Healthcare Compliance Risk Assessment, including updating the risk catalog, creating risk assessment surveys, data collection, analysis, and report drafting
Analyze compliance monitoring data to identify trends, risks, and areas of concern; track findings and oversee remediation
Collaborate with third-party vendors to support monitoring activities and continuously enhance the monitoring program
Develop and maintain dashboards, visual analytics, and reports using tools such as Excel, Tableau, and Power BI to provide ongoing high-quality insights into compliance risks and program effectiveness to detect and mitigate risks
Support federal and state transparency reporting efforts, including Sunshine Act compliance and other global transparency requirements
Maintain and update healthcare compliance policies and procedures based on evolving regulatory requirements and risk assessments
Assist with healthcare compliance-related training and education programs to ensure internal awareness of current laws, regulations, and industry standards
Identify and implement initiatives to enhance the efficiency and effectiveness of the healthcare compliance program leveraging technology and best practices
Work collaboratively with internal teams across Commercial, Legal, Medical, Finance, IT, and HR to ensure alignment of compliance activities and facilitate knowledge sharing
Provide compliance operational consultation and support for consulting engagements, advisory boards, sponsorships, and other business activities
Requirements:
Bachelor's degree required
At least 12 years of experience in healthcare compliance, auditing, or ethics and compliance operations within the biopharmaceutical industry
Proven experience managing healthcare compliance monitoring and risk assessment programs
Experience with laws, regulations and industry guidance that affect the pharmaceutical industry including, but not limited to, OIG and PhRMA guidelines, healthcare standard operating procedures, and anti-bribery and anti-kickback laws
Advanced proficiency in Excel; experience with Tableau, Power BI, or similar data analytics tools preferred
Strong analytical skills with ability to work with large datasets to identify trends and compliance risks
Experience with AI monitoring tools and systems for automated compliance insights
Excellent project management and multitasking abilities
Strong verbal and written communication skills to clearly convey complex information to diverse audiences
Self-motivated, agile, and able to work independently as well as collaboratively in a team environment
Agility to take on new projects and additional responsibilities, as required
High level of integrity with the ability to maintain the protection of proprietary and confidential information
Ability to work in a fast paced and dynamic work environment with a strong work ethic and positive attitude
Occasional domestic travel (up to 20%)
The pay scale for this position is $140,104 to $189,893
- Location:
- Carlsbad, CA, United States
- Category:
- Management Occupations