Director - Compliance Counsel

Ionis Pharmaceuticals, Inc.•Boston, MA

98d•$241,988 - $276,900•Hybrid

About The Position

Reporting to the VP, Compliance, the Director, Compliance Counsel serves as a senior legal and compliance advisor and strategic partner to Ionis’ business and functional leaders. This role will help maintain and enhance an effective, right-sized healthcare and corporate compliance program as Ionis continues to grow as a commercial biopharmaceutical company. Provides proactive, practical and business-focused advice across the organization, including to Commercial, Marketing, Patient Services, Market Access, Medical Affairs, Regulatory Affairs, Clinical Development, Finance, Human Resources, Information Technology and other functions. The Director, Compliance Counsel will advise on matters involving marketed products and products in development, promotional and educational activities, healthcare professional and healthcare entity interactions, grants and sponsorships, policy development, risk management, investigations, monitoring and training. Requires a problem-solving mindset, mature and reliable judgment, a high degree of collaboration, and the ability to influence decision-making while maintaining independence, confidentiality and the highest standards of integrity. The successful candidate will be hands-on, adaptable and committed to building a culture in which Compliance is viewed as a trusted strategic partner and employees are accountable for ethical conduct.

Requirements

Juris Doctorate or equivalent law degree and admission to a State Bar required.
Minimum of 5-7 years of professional legal experience at a law firm or in-house legal department, with significant experience working in or serving the life sciences industry; experience appropriate for a Director/Executive Director-level role is preferred.
Direct experience with legal and compliance matters relevant to a public biopharmaceutical company, including product advertising and promotion, commercial contracting, healthcare professional interactions, training, investigations, risk assessments, monitoring, policy drafting and implementation.
Knowledge of laws, regulations and industry guidance affecting the pharmaceutical industry, including the FDCA, FDA guidance, fraud and abuse and anti-kickback statutes, OIG guidance and advisory opinions, PhRMA guidelines, state marketing compliance and transparency laws, and applicable privacy requirements.
Demonstrated ability to grasp statutory and regulatory concepts quickly, proactively identify and analyze potential legal and compliance issues, and provide thoughtful, creative and business-focused advice and solutions.
Experience conducting or overseeing legal and compliance review of materials submitted for Promotional and Medical Review.
Experience developing and implementing compliance policies, training, risk assessments, monitoring plans and other elements of an effective healthcare compliance program.
Experience supporting or conducting internal investigations and recommending corrective and preventive actions is a plus.
Knowledge or experience with managed markets, payer and PBM contracting, patient support programs, government pricing, grants, investigator-initiated studies or sponsorships is a plus.
Strong sense of integrity and independent judgment, with the ability to balance business interests and compliance obligations.
Proven capacity to cultivate strong client relationships, influence leadership and drive sound decision-making in a dynamic, innovative business climate.
Excellent analytical skills and attention to detail, accuracy and deadlines.
Exceptional communication, presentation, interpersonal and collaboration skills; an inclusive individual who thrives in a team-oriented environment.
Driven by Ionis’ patient-centric mission to improve the lives of patients living with serious diseases.

Nice To Haves

Experience supporting or conducting internal investigations and recommending corrective and preventive actions is a plus.
Knowledge or experience with managed markets, payer and PBM contracting, patient support programs, government pricing, grants, investigator-initiated studies or sponsorships is a plus.

Responsibilities

Partners with the VP, Compliance, the Chief Compliance Officer, and Compliance/Privacy team to build, implement and maintain a robust healthcare and corporate compliance program that is appropriately scaled to Ionis’ business, products, risk profile and growth.
Provides proactive legal and compliance guidance to business partners on strategic and tactical initiatives, including commercial, medical, regulatory and corporate activities.
Provides advice, guidance and counsel on sales and marketing strategies, programs, policies, practices and initiatives with respect to applicable healthcare laws, regulations, guidance, government enforcement positions and industry codes, including the FDCA, FDA guidance, fraud and abuse laws, anti-kickback statutes, federal and state transparency laws, OIG Advisory Opinions and the PhRMA Code.
Serves as the Legal/Compliance representative on cross-functional Promotional Review and Medical Review Committees, providing feedback and direction on advertising, promotional, educational and medical materials and activities.
Reviews and provides legal and compliance guidance on financial and other interactions with healthcare professionals, healthcare entities, patients and other individuals or organizations in a position to influence healthcare decisions, including payers, advocacy groups, distributors and other third parties.
Supports medical and commercial development for assigned products, including regulatory and medical strategies, product safety, product liability analyses, and risk mitigation activities as appropriate.
Develops and updates compliance policies, procedures, standards and guidance in collaboration with business and functional stakeholders, ensuring they reflect applicable laws, regulations, guidance, industry codes and company risk assessments.
Supports the operation of the Company’s Executive Compliance Committee, including preparation of materials, reporting, and follow-up on actions and commitments.
Develops and delivers engaging compliance and ethics training and other content for employees, leaders, contractors and external consultants, including live large-group presentations and role-based education.
Fosters a strong compliance, ethics and speak-up culture by helping employees understand and be accountable for their roles in building a compliant and ethical organization.
Conducts or supports investigations into allegations of violations of applicable laws, regulations or company policies, maintains appropriate confidentiality, and recommends corrective and preventive actions where appropriate.
Supports compliance risk assessments as necessary and collaborates with Compliance Operations to assist with monitoring, auditing and other oversight and remediation plans for key risk areas.
Participates in internal risk management initiatives, including reviews of CME grants, investigator-initiated studies, grants, sponsorships and other activities, as applicable.
Stays informed of developments in laws, regulations, enforcement trends and industry practices affecting Ionis, and translates relevant developments into practical advice, policies, training and risk mitigation actions.
Proactively identifies legal and compliance risks, opportunities and mitigating actions, and collaborates across business functions to implement sound, practical solutions.
Engages and efficiently manages external counsel and other advisors as appropriate.
Performs other responsibilities in support of Compliance team, functional and corporate strategies and goals.