Director, Compliance Operations

Company: Ionis Pharmaceuticals, Inc.
Location: Boston
Posted on: February 1, 2025

Job Description:

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 are pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With five currently marketed medicines for serious diseases and an expansive late-stage pipeline, we continue to build upon our groundbreaking innovations in science and technology to provide greater value to patients; and we 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 our success is a direct result of the exceptional talent 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 and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.We invite you to apply and join us if you're passionate about the opportunity to have meaningful impact on patients in need, our employees, and our organization. Experience and contribute to our unique culture while you develop and expand your career!DIRECTOR, COMPLIANCE OPERATIONSSUMMARY:Reporting to the SVP Chief Compliance and Quality Assurance Officer, the Director, Compliance Operations will be responsible for driving the development, implementation, oversight, and continuous improvement of Ionis' healthcare compliance program. This individual will serve as a business partner to all business functions supporting commercial and pipeline products, including medical, clinical, and commercial departments, and will operationalize the compliance program processes.As a key leader and resource, the individual must have the appropriate level of business acumen and compliance experience, as well as sound judgment to advise the business on complex compliance processes and compliance related issues. The individual will communicate effectively with all levels of the organization, including sales representatives and executives.RESPONSIBILITIES:

• Maintain effective lines of communication with the business about compliance by generating awareness of the Ionis Compliance Helpline, Code of Ethics and Business Conduct, policies and procedures, and new compliance developments. This also includes responsibility for ensuring constant and easy access to compliance policies, forms and process information.
• Lead compliance risk assessments and create and execute plans to mitigate identified risks.
• Create the annual auditing and monitoring plan, ensuring milestones are met, communicating progress, and making necessary adjustments. Also responsible for planning and execution of audits within the plan (e.g., Healthcare Professional ("HCP") payments, email audits).
• Serve as a strategic business partner and provide proactive compliance support to designated business areas, such as commercial operations, sales, marketing, medical affairs, and clinical operations and development departments.
• Oversee and drive the implementation of a global transparency reporting infrastructure to ensure compliance with U.S. Sunshine/Open Payments, state, and ex-US transparency disclosure laws.
• Oversee the timely and accurate data submissions for U.S. Sunshine/Open Payments, state, and ex-US transparency disclosure laws. Analyze data to identify compliance risks and identify and execute on remedial strategies.
• Oversee development, creation, and execution of employee and consultant/vendor compliance training materials and curricula (including sales and field training).
• Assist with compliance investigations, as necessary.
• Draft and revise compliance policies and procedures, working with Legal and other Compliance colleagues, to ensure compliance with applicable laws, regulations and codes (excluding cGMP, cGCP and other GxP guidelines). This includes tracking policy versions and ensuring that updates are successfully implemented and rolled out.
• Assist with compilation and communication of materials presented at quarterly management level Compliance meetings.
• Oversee review of sponsorship and exhibit opportunities and HCP arrangements for FMV and compliance with Ionis policies and U.S. and ex-U.S. laws.
• Ensure processes employed to mitigate compliance risks are operating correctly and efficiently, such as debarment and exclusion screening, HCP engagements & FMV, and speaker bureaus.
• Act as lead for implementation and upkeep of systems that are fully or partially owned by Compliance, such as transparency reporting data warehouse / platforms, HCP engagement.
• Provide content for and as needed, participate in, Board of Directors compliance program updates.
• Stay abreast of industry law changes and inform business of the same and participate in various Legal & Compliance Department projects and initiatives as needed.
• Periodic travel within the U.S.REQUIREMENTS:
• Bachelor's Degree Required
• Advanced degree (e.g., JD, MBA) Preferred
• At least 12-15 years of ethics, compliance or a mix of compliance and legal experience in an organization subject to global biopharmaceutical, medical device or other relevant healthcare compliance laws and regulations
• Experience managing a team of compliance professionals
• Expertise analyzing multiple data sets, and ability to expertly identify and summarize data trends for stakeholders
• Experience working with all levels of management and consulting with key business stakeholders
• Experience creating effective training
• Experience with U.S. and ex-US reporting and aggregate spend laws
• Some global compliance experience preferred
• Knowledge of laws and regulations applicable to global pharmaceutical companies, e.g., the Foreign Corrupt Practices Act/Anti-Bribery and Anti-Corruption laws, U.S. federal and state anti-kickback and false claims laws, and PhRMA Code on Interactions with Healthcare Professionals
• Solid working knowledge of other laws, regulations, and industry standards
• Exceedingly detail oriented and organized
• Firm and strong when necessary, yet flexible and solution-oriented
• High ethical standards and integrity
• Consummate team player with excellent judgment and interpersonal skills
• Ability to communicate effectively with all levels of management and employees
• Demonstrable experience taking ownership of issues and providing timely, actionable guidance
• Excellent project management skills with the ability to manage multiple priorities simultaneously
• Self-starter with demonstrated leadership skills and ability to meet goals given limited supervision; able to exercise sound judgment in balancing risks in ambiguous and complex situations and escalating matters appropriately
• Demonstrated superior ability to identify areas for improvement in controls, systems, and processes and implement effective solutions
• Ability to work with large amounts of data to analyze information while still seeing the "big picture"
• Confidence and professionalism to handle difficult conversations and discretion on sensitive matters
• Flexibility to work in a fast paced and dynamic work environment with a strong work ethic and positive attitude
• Periodic travel within the U.S.Please visit our website, for more information about Ionis and to apply for this position; reference requisition # IONIS003511Ionis offers an excellent benefits package! Follow this link for more details: Ionis BenefitsThe pay scale for this position is $185,682 to $240,000NO PHONE CALLS PLEASE. PRINCIPALS ONLY.Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.
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Keywords: Ionis Pharmaceuticals, Inc., Newton , Director, Compliance Operations, Executive , Boston, Massachusetts