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4 дня назад

Director - Compliance Counsel

241 988 - 276 900$
Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
director
Английский
b2
Страна
US/Ireland
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Director - Compliance Counsel (Healthcare Compliance): Advising business and functional leaders on healthcare and corporate compliance for marketed and pipeline biopharmaceutical products with an accent on promotional review, healthcare professional interactions, risk management, investigations, and policy development. Focus on building scalable compliance programs, interpreting FDA and healthcare laws, developing training, and guiding remediation across a public biopharmaceutical organization.

Location: San Diego, California; Boston, Massachusetts; or remote within the United States

Salary: $241,988–$276,900

Company

Ionis is a commercial biopharmaceutical company developing RNA-targeted medicines and gene-editing approaches for serious diseases.

What you will do

  • Advise commercial, medical, regulatory, clinical, finance, HR, IT, and other functions on healthcare and corporate compliance matters.
  • Build, implement, and maintain a scalable compliance program aligned with the company’s products, risks, and growth.
  • Review promotional, educational, advertising, and medical materials through cross-functional review committees.
  • Develop compliance policies, procedures, training, risk assessments, monitoring plans, and remediation activities.
  • Support investigations, grants, sponsorships, pricing activities, patient programs, and interactions with healthcare professionals and entities.
  • Partner with senior leaders, manage external counsel, and translate legal and regulatory developments into practical business guidance.

Requirements

  • Juris Doctorate or equivalent law degree and admission to a state bar.
  • 5–7 years of legal experience in a law firm or in-house legal department, with significant life sciences experience.
  • Experience advising a public biopharmaceutical company on advertising and promotion, healthcare interactions, investigations, risk assessments, monitoring, and compliance policies.
  • Knowledge of the FDCA, FDA guidance, fraud and abuse laws, anti-kickback statutes, OIG guidance, PhRMA guidelines, state transparency laws, and privacy requirements.
  • Strong independent judgment, analytical ability, communication skills, and capacity to influence business leaders.
  • Must work in San Diego, Boston, or remotely within the United States.

Nice to have

  • Experience with internal investigations and corrective and preventive actions.
  • Knowledge of managed markets, payer and PBM contracting, patient support programs, government pricing, grants, investigator-initiated studies, or sponsorships.
  • Experience appropriate for a Director or Executive Director-level role.

Culture & Benefits

  • Patient-centric mission focused on improving the lives of people with serious diseases.
  • Collaborative environment emphasizing innovation, scientific excellence, integrity, and ethical conduct.
  • Onsite, hybrid, and remote work environments designed to support lasting professional relationships.
  • Excellent benefits package.

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