Ionis Pharmaceuticals
Assistant/Associate Director, Compliance Operations, Systems & Process Lead
Ionis Pharmaceuticals, Boston, Massachusetts, us, 02298
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 or ASSOCIATE DIRECTOR, COMPLIANCE OPERATIONS – SYSTEMS & PROCESS LEAD Summary The Assistant / Associate Director Compliance Operations – Systems and Process Lead, reports to the Head of Compliance Operations and is responsible for designing, implementing, and managing technology and process solutions supporting Ionis’s healthcare fraud and abuse compliance operations. Key focus areas include HCP Engagements, Transparency Reporting, Risk Assessment, and Monitoring. This role ensures compliance systems and processes are efficient, scalable, and aligned with regulatory requirements and company policies.
This role is flexible for remote candidates in the U.S., with preference given to individuals located in or near the Boston, MA area to enable periodic on-site collaboration.
The position partners cross-functionally with Commercial, Medical, R&D, IT, Legal, Finance, Procurement and HR to promote a strong culture of ethics and compliance while driving digital innovation and operational excellence.
Responsibilities
Serve as the system owner and operational lead for compliance tools, including HCP Engagements, Transparency Reporting, Risk Assessment, and Monitoring, Case Management/Hotline system
Oversee daily operations, system configuration, user access, and data governance to ensure accuracy, reliability, and audit readiness
Translate business processes into compliance system requirements and configurations through cross-functional collaboration
Lead the RFP process with compliance system vendors and manage vendor performance, contracts, and budgets
Manage upgrades, enhancements and change control processes
Provide guidance on transparency data capture and transparency reporting workflows to support accurate data for transparency reporting and audit readiness
Identify opportunities to automate manual compliance processes and streamline workflows
Partner with IT teams to deploy AI-enabled tools and digital workflows that improve efficiency and risk detection
Develop compliance dashboards and analytics to provide actionable insights
Create and maintain process documentation, SOPs, and job aides ensuring consistent execution of compliance processes
Provide end-user training, communications, and change management to drive adoption of new technologies
Conduct monitoring activities (live, transactional, and desktop) to assess compliance with company policies, procedures and regulatory requirements
Requirements
Bachelor’s degree required
For the Assistant Director position, 8 years of experience in healthcare compliance operations, specifically risk and system management, within the biopharmaceutical industry, or 6 years; with an advanced degree, relevant compliance certifications is a plus; other related experience may be considered
For the Associate Director position, 12 years of experience in healthcare compliance operations, specifically risk and system management, within the biopharmaceutical industry, or 8 years; with an advanced degree, relevant compliance certifications is a plus; other related experience may be considered
Proven experience implementing and managing healthcare compliance risk management technologies and processes
Expertise in system configuration, data governance, and process optimization
Excellent problem-solving skills with attention to detail and accuracy
Strong project management and vendor management experience
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, transparency reporting, an anti-bribery and anti-kickback laws
Demonstrated ability to leverage technology (including AI/ML) to automate compliance tasks and identify risks
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
Ability to translate regulatory requirements into practical, system-enabled processes
Strong verbal and written communication skills to clearly convey complex information to diverse audiences
Self-motivated, 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%)
Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition
IONIS003855
Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits
Full Benefits Link: https://www.ionis.com/careers/working-at-ionis/#:~:text=our employee spotlight-,Benefits,-Employees are rewarded
The pay scale for this position is $104,800 - $190,514
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.
Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
#J-18808-Ljbffr
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 or ASSOCIATE DIRECTOR, COMPLIANCE OPERATIONS – SYSTEMS & PROCESS LEAD Summary The Assistant / Associate Director Compliance Operations – Systems and Process Lead, reports to the Head of Compliance Operations and is responsible for designing, implementing, and managing technology and process solutions supporting Ionis’s healthcare fraud and abuse compliance operations. Key focus areas include HCP Engagements, Transparency Reporting, Risk Assessment, and Monitoring. This role ensures compliance systems and processes are efficient, scalable, and aligned with regulatory requirements and company policies.
This role is flexible for remote candidates in the U.S., with preference given to individuals located in or near the Boston, MA area to enable periodic on-site collaboration.
The position partners cross-functionally with Commercial, Medical, R&D, IT, Legal, Finance, Procurement and HR to promote a strong culture of ethics and compliance while driving digital innovation and operational excellence.
Responsibilities
Serve as the system owner and operational lead for compliance tools, including HCP Engagements, Transparency Reporting, Risk Assessment, and Monitoring, Case Management/Hotline system
Oversee daily operations, system configuration, user access, and data governance to ensure accuracy, reliability, and audit readiness
Translate business processes into compliance system requirements and configurations through cross-functional collaboration
Lead the RFP process with compliance system vendors and manage vendor performance, contracts, and budgets
Manage upgrades, enhancements and change control processes
Provide guidance on transparency data capture and transparency reporting workflows to support accurate data for transparency reporting and audit readiness
Identify opportunities to automate manual compliance processes and streamline workflows
Partner with IT teams to deploy AI-enabled tools and digital workflows that improve efficiency and risk detection
Develop compliance dashboards and analytics to provide actionable insights
Create and maintain process documentation, SOPs, and job aides ensuring consistent execution of compliance processes
Provide end-user training, communications, and change management to drive adoption of new technologies
Conduct monitoring activities (live, transactional, and desktop) to assess compliance with company policies, procedures and regulatory requirements
Requirements
Bachelor’s degree required
For the Assistant Director position, 8 years of experience in healthcare compliance operations, specifically risk and system management, within the biopharmaceutical industry, or 6 years; with an advanced degree, relevant compliance certifications is a plus; other related experience may be considered
For the Associate Director position, 12 years of experience in healthcare compliance operations, specifically risk and system management, within the biopharmaceutical industry, or 8 years; with an advanced degree, relevant compliance certifications is a plus; other related experience may be considered
Proven experience implementing and managing healthcare compliance risk management technologies and processes
Expertise in system configuration, data governance, and process optimization
Excellent problem-solving skills with attention to detail and accuracy
Strong project management and vendor management experience
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, transparency reporting, an anti-bribery and anti-kickback laws
Demonstrated ability to leverage technology (including AI/ML) to automate compliance tasks and identify risks
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
Ability to translate regulatory requirements into practical, system-enabled processes
Strong verbal and written communication skills to clearly convey complex information to diverse audiences
Self-motivated, 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%)
Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition
IONIS003855
Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits
Full Benefits Link: https://www.ionis.com/careers/working-at-ionis/#:~:text=our employee spotlight-,Benefits,-Employees are rewarded
The pay scale for this position is $104,800 - $190,514
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.
Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
#J-18808-Ljbffr