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Years of Experience
Date Last Verified
Corporate Counsel The candidate will assist with implementation of the legal oversight of SPP interactions to ensure compliance with the recommendations from recent settlements including: creation of dash board that compares services discounting by product per SPP (esp. those that are payer owned); routine monitoring of Quarterly Business Reviews with Specialty pharmacy to ensure performance to the contract; review of Specialty pharmacy initiative at least annually by Compliance; and Specialty Access Solutions Center Of Excellence (SAS COE) working on centralized place to house contracts, business rationale forms and then updates to SAS COE policy that will be required by Firmâ€™s Compliance Program. Will be responsible for assisting with proactive compliance effectiveness reviews, coordinating with outside law firms that are engaged to conduct such reviews, and supporting the ongoing development and enhancement of adherence programs and internal policies and procedures to satisfy evolving industry and regulatory compliance requirements within the specialty pharmacy space in the US. Navigating complex matrix organizations in order to effectively communicate and coordinate with business unit subject matter experts and regional level national account directors. Assist with specialty pharmacy adherence program activities, systems, controls and reporting on specialty pharmacy adherence programs for the U.S., including: Advising stakeholders on the applicability of federal healthcare requirements relevant to their business activities. Managing contracting and engagement with Drug Safety Unit for CEP program implementation to assure appropriate reporting of adverse events by specialty pharmacy personnel who are performing services for and on behalf of Firm. Collaborating with outside counsel to develop legal perspectives on elements of specialty pharmacy adherence programs. Drafting and negotiating agreements with vendors, contractors, and other parties to ensure compliance obligations are met. Prepare and manage preparation of reports on SAS COE and participate in activities related to oversight of Firmâ€™s Compliance Program as it related to specialty pharmacy. Ensure continued compliance with SAS COE policies and procedures. Advise on the applicability of federal healthcare regulatory requirements and implications on business activities. Develop and present training related to specialty pharmacy activities. Coordinate with Legal and Compliance colleagues to enhance policies and systems controls to address compliance risk areas; interpreting laws, regulations and policies relating to SAS COE areas. Draft and coordinate on preparation of compliance-related reports and presentations for Firm senior management and the Regulatory and Compliance Committee of the Board of Directors related to specialty pharmacy programs.
Qualification and Experience
The candidate must have 12-14 years practicing law or experience in risk management/ compliance in the pharmaceutical or healthcare industry including significant experience with drafting and negotiating contracts. Should have BS or BA degree. JD degree (and admission to practice law in United States) is required. Experience negotiating and/or managing programs related to service agreements under the personal services safe harbor to the anti-kickback statute and regulations and significant experience with US healthcare laws is needed. Understanding of healthcare-related laws and regulations and industry standards required, including the federal false claims act, federal anti-kickback statement, OIG regulations and guidance and pharmacovigilance issues is must. Strong interpersonal skills to work with others within and outside the Company to identify and manage compliance risks are necessary.
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