Director - Compliance Counsel

Ionis Pharmaceuticals, Inc.

United States

Sur place

USD 180 000 - 260 000

Plein temps

14 jours+

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Avantages offerts par ce poste

Remote or onsite work

Résumé du poste

Ionis, a biopharmaceutical company focused on RNA-targeted medicines, gene editing and neuroscience, seeks a Director, Compliance Counsel to provide strategic legal and compliance leadership.

You will develop and maintain healthcare and corporate compliance programs, advise on promotional and regulatory activities, review marketing materials, oversee interactions with health professionals, and support investigations and policy training.

Qualifications

  • JD and bar admission in a U.S. state.
  • 5–7+ years of life sciences legal experience.
  • Strong knowledge of FDA regulations, anti-kickback, fraud laws, and industry codes.
  • Experience with promotional review, compliance policies, and investigations.
  • Excellent judgment, integrity, and relationship-building skills.

Responsabilités

  • Develop and maintain healthcare and corporate compliance programs.
  • Advise on promotional, medical, regulatory, and commercial activities.
  • Review marketing and educational materials.
  • Oversee interactions with healthcare professionals and entities.
  • Support product safety, risk mitigation, and investigations.
  • Foster a strong compliance culture through training and policy development.
  • Manage internal risk assessments and monitor compliance risks.

Connaissances

FDA regulations
Promotional review
Investigations
Regulatory compliance
Relationship-building

Formation

JD, admitted to a State Bar

Description du poste

Role:

Director, Compliance Counsel at Ionis, providing strategic legal and compliance advice to support a growing biopharmaceutical company specializing in RNA-targeted medicines, gene editing, and neuroscience.

Responsibilities:
  • develop and maintain healthcare and corporate compliance programs
  • advise on promotional, medical, regulatory, and commercial activities
  • review marketing and educational materials
  • oversee interactions with healthcare professionals and entities
  • support product safety, risk mitigation, and investigations
  • foster a strong compliance culture through training and policy development
  • manage internal risk assessments and monitor compliance risks
Qualifications:
  • JD, admitted to a State Bar
  • 5-7+ years of legal experience in or with the life sciences industry
  • strong knowledge of FDA regulations, anti-kickback, fraud laws, and industry codes
  • experience with promotional review, compliance policies, and investigations
  • excellent judgment, integrity, and relationship-building skills
HighValue:
  • biopharma (RNA therapies, gene editing, neurology)
  • compliance program leadership
  • legal review of promotional and medical activities
  • regulatory guidance
  • internal investigations
  • industry-specific laws
WorkSetup:

remote or onsite in San Diego, CA, Boston, MA.

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