Senior Director, Compliance
Revolution MedicinesAbout the role
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
The individual will serve as counsel for a diverse set of clients across the company and frequently interacting with and providing substantive advice to Commercial, Marketing, Regulatory Affairs, and other departments concerning a broad range of legal, regulatory and compliance issues, including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, relevant industry codes, the Sunshine Act, and the Prescription Drug Marketing Act, among others. will design, employ, and drive compliance programs, manage investigations, and train employees. This position reports to the Vice President, Legal Compliance.
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Serve as legal reviewer on promotional and medical review committees working cross functionally with commercial, regulatory, and medical affairs to help ensure consistency, accuracy, and compliance of materials for promotional, medical affairs, market research, advisory boards, training
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Assist with functional teams to review internal and external communications such as social media posts, corporate presentations/webinars and press releases.
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Provide legal counsel on relevant policies, procedures and training to ensure company compliance with policies, state and federal laws and regulations.
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Collaborate with department leaders to understand risk considerations, implement compliance-related policies, and support ongoing compliance initiatives.
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Update risks assessment and develop risk mitigation strategies and methods to operationalize compliance.
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Establish strong relationships with key internal stakeholders to understand current and future compliance needs relating to reporting.
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Manage compliance investigations.
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Develop and manage an effective compliance communication program for the organization, including promoting use of the compliance hotline, heightened awareness of the Code of Conduct and applicable compliance policies, procedures, ethics, and understanding of new and existing compliance issues and related policies and procedures.
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Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including anti-kickback and fraud and abuse laws, transparency laws, Sunshine Act, OIG and DOJ guidelines, HIPAA, FDA, CMS, ACA, and industry standards, such as the PhRMA Code on Interactions with Healthcare Providers.
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Ensure company compliance with policies, state and federal laws and regulations.
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Research, draft, and update corporate compliance policies and standard operating procedures.
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Resolve routine legal matters in the practice area with direct supervision as needed.
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Where necessary, assist with the review and negotiation of agreements (including consulting agreements and other corporate agreements) that may impact healthcare compliance.
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Help select and direct the work of outside counsel, define project objectives and manage projects.
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Train new employees in company standard operating procedures and compliance, and update and create additional training content.
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Participate in CMS, state or health plan audits and reviews.
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Gather and audit data, prepare, and validate the federal and state transparency reports such as the Sunshine Act.
Required Skills, Experience and Education:
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Law degree from an ABA accredited law school and in good standing with the state bar of the jurisdiction.
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Minimum of 13 years of relevant experience.
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Excellent written and verbal communication skills, including the ability to communicate complex legal issues in a simple, understandable manner with colleagues across the company.
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Strong collaborative skills, able to build partnerships internally and with external partners at all levels of the organization.
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Strong organization and time management skills with flexibility, creativity, resourcefulness to successfully prioritize and manage multiple, competing priorities simultaneously.
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Knowledge of legal and regulatory requirements related to consumer privacy, data
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