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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/Director, Compliance Counsel
SUMMARY:
Reporting to the Director of Compliance, the Associate Director/Director/Compliance Counsel will have direct responsibility for and assist with driving, implementing, and continuously improving all elements of the Ionis US Compliance Program. This role will focus on dedicated and strategic partnership with multiple client groups, including teams within Ionis’ Marketing, Patient Services, Market Access, Medical Affairs, and Commercial functions, providing advice on matters related to promotional and educational activities, engagements with healthcare providers and entities, and other applications of healthcare and regulatory compliance in the biopharmaceutical industry.
This role will also have significant interaction with Commercial functions, Medical Affairs, Regulatory Affairs, Clinical Development, IT and other functions throughout Ionis. This position requires a problem-solving mindset, a high degree of collaboration with internal clients and colleagues, and the ability to exercise mature and reliable judgment in the company’s fast-paced environment.
For this position, it is preferred to be on-site in either our Carlsbad, CA or Boston, MA offices. It’s open to working fully remote. For remote working, the expectation includes visits to our Carlsbad or Boston office.
RESPONSIBILITIES:
- Provides advice, guidance and counsel to commercial, medical and corporate teams on sales and marketing strategies, programs, policies, practices and initiatives with respect to compliance with relevant U.S. healthcare laws, guidance documents or opinions, and industry codes (FDCA, FDA guidance, fraud and abuse laws, anti-kickback statutes, federal and state transparency laws, OIG Advisory Opinions, PhRMA Code, etc.).
- Assists with strategic projects designed to fulfill the needs of and enhance the effectiveness of the Ionis Compliance Program and drives results-oriented process improvement.
- Assists with internal compliance investigations, ensuring legal compliance and managing risk. Assist with escalations as needed. Enforces standards and ensures appropriate follow-up action.
- Assists in remediating findings from investigations, audits, monitoring, and other assessments, keeping applicable team members apprised of relevant information
- Serves as the legal representative on cross-functional Promotional Review/Medical Review Committees to provide legal feedback and direction on advertising, promotional, and disease state awareness materials submitted for review.
- Supports medical and commercial development for assigned products, including regulatory and medical strategies, product safety, product liability analyses and risk-mitigation activities and label development.
- Reviews and provides legal guidance on financial and other interactions with healthcare professionals, patients, or others in a position to influence healthcare decisions (e.g., payers, advocacy groups, distributors, etc.) to ensure compliance with applicable laws and regulations.
- Supports execution of a robust healthcare compliance program, including creation and enforcement of company policies and procedures, risk assessments and ongoing monitoring.
- Supports Compliance leadership with change management activities. This will include educating and influencing key stakeholders about new requirements during the development of new documents and updates to existing documents to meet the changing nature of business activities. It will also include the routine maintenance of effective control documents.
- Provides legal and compliance training to Ionis personnel.
- Proactively identifies risks, opportunities and mitigating actions, and collaborates across business functions to implement.
- Partners with the Chief Compliance Officer and Compliance team to implement an effective ethics and compliance program.
- Stays informed of new laws, regulations, and industry trends affecting the company, and assists with the development of policies and training as needed
REQUIREMENTS:
- Strong sense of integrity, understanding of business transaction transparency, and the ability to balance business interests with the need to exercise independent judgment.
- Proven capacity to cultivate strong client relationships and successfully influence leadership in a dynamic, innovative business climate.
- Juris Doctorate or equivalent law degree required.
- Admission to a State Bar
- For the Associate Director position, a minimum of 8 years of professional work experience at a law firm or in-house legal department and/or a minimum of 8 years supporting the pharmaceutical or biotech industry as in-house counsel (pharma/biotech preferred) or in a law firm, including experience in regulatory law and commercial-related matters.
- For the Director position, a minimum 12 years of professional work experience at a law firm or in-house legal department and/or a minimum of 12 years supporting the pharmaceutical or biotech industry as in-house counsel (pharma/biotech preferred) or in a law firm, including experience in regulatory law and commercial-related matters.
- A thorough understanding of regulatory and legal frameworks governing the sales and marketing of approved medicines, and regulatory framework for investigational medicines.
- Demonstrated ability to grasp statutory and regulatory concepts quickly, proactively identify and analyze potential legal issues and provide thoughtful and creative business-focused legal advice and solutions.
- Experience conducting legal review of materials submitted for Medical/Regulatory/Legal (MLR) Review.
- Knowledge of laws, regulations, and industry guidance that affect the pharmaceutical industry, including FDCA, FDA guidance, fraud and abuse, and anti-kickback statutes, OIG and PhRMA guidelines, and state marketing compliance laws.
- Knowledge and experience with managed markets, payer and PBM contracting, patient support programs and/or government pricing a plus.
- Ability to work independently and in a fast-paced environment and handle multiple complex and confidential tasks.
- Ability to analyze and interpret technical procedures, government regulations, and legal documents.
- Excellent communication and interpersonal skills.
- Exceptional attention to detail and deadlines.
Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS003739
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%20employee%20spotlight-,Benefits,-Employees%20are%20rewarded
The pay scale for this position is $180,100 to $293,638
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.
Salary- $180,100 - $293,638
