49 applicants

Company

BeiGene · 6 hours ago

Director, Compliance – North America

Remote (US)

Full-time

Remote

Director/Executive

$182K/yr - $242K/yr

10+ years exp

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Responsibilities

Serve as the primary compliance contact for the U.S. and Canadian markets, providing proactive, solutions-oriented support to Commercial, Market Access, Medical Affairs, Clinical, and R&D teams.

Shape a forward-looking compliance strategy that aligns with company goals and adapts to regulatory shifts, industry trends, and internal dynamics.

Establish clear, measurable performance metrics for compliance activities, tracking and adjusting as needed to ensure strategic goals are met efficiently and effectively.

Lead a risk-based methodology for activity reviews, offering expert compliance insights and consulting relevant stakeholders or subject matter experts as necessary.

Design and implement both formal and informal training programs, along with other internal communication efforts, to address compliance risks, reinforce program messages, and build a culture centered on ethics and integrity.

Actively participate in both standing and ad hoc committees, contributing compliance expertise and insights to cross-functional initiatives.

Partner with business stakeholders to anticipate and address emerging compliance trends, adjusting processes as needed to maintain compliance integrity within a dynamic environment.

Provide actionable, business-oriented compliance solutions that align with an evolving legal landscape, supporting BeiGene’s commitment to ethical operations.

Lead live compliance monitoring efforts and support ongoing back-end monitoring activities, including measurement, tracking, and reporting on compliance performance.

Guide and support compliance audits, working collaboratively with stakeholders to ensure that any required corrective actions are implemented promptly and effectively.

Use monitoring and audit data to identify and present trends to leadership, offering coaching, recommendations, and corrective actions to address compliance challenges.

Oversee internal compliance policies, procedures, and communication channels, managing resources like the ethics hotline and intranet compliance content to ensure accessibility and transparency.

Drive efforts to build and communicate a robust compliance culture across the organization, emphasizing integrity and ethical behavior as core values.

Maintain open, transparent communication channels, promptly responding to stakeholder inquiries and offering timely, constructive feedback.

Pursue continuous improvement by actively seeking stakeholder feedback, continuously enhancing the quality, effectiveness, and impact of compliance support.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Healthcare ComplianceRisk ManagementU.S. Healthcare LawsCompliance Strategy DevelopmentTraining Program DesignAuditing SkillsData AnalysisMicrosoft SuiteTeam Management

Required

Bachelor of Arts or Bachelor of Science required; J.D. or other advanced degree preferred but not required.

Minimum of ten years of combined experience in healthcare compliance, including in-house experience.

Strong expertise in compliance with laws, regulations, and industry codes relevant to the development and commercialization of pharmaceutical products.

Working knowledge and experience with U.S. healthcare fraud and abuse laws (e.g., Anti-kickback statute, False Claims Act), FDCA, FDA guidance, OIG Compliance Program Guidance, OIG advisory opinions, and federal and state transparency and compliance program disclosure laws, and U.S. and international industry codes (e.g., PhRMA, EFPIA, IFPMA).

Excellent communication skills (oral and written; strong interpersonal skills in both one-on-one and group settings.

Ability to maintain a high degree of confidentiality in dealing with sensitive matters.

Acts with a sense of urgency, with high motivation and ability to take initiative, follow through and complete projects in a professional and expeditious manner.

Strong presentation skills, including creating and delivering presentations to various size audiences at all levels of the organization.

Strong analytical and problem-solving skills.

Strong attention to detail and accuracy.

Strong collaborative, interpersonal and oral communication skills.

Preferred

Ability to work effectively in a global environment and good at managing work under a matrix organization structure and comparably complicated environment.

Management experience and ability to mentor and supervise a team of professionals.