The Commercial Solutions Platform Team is looking to fill a Corporate Counsel position to assist with contracting for Specialty Pharmacy adherence programs and with implementation of these service arrangements. The individual will assist with finalization of the 40 Specialty Pharmacy MSAs – and 200 active SOWs across 11 specialty & rare disease products. The agreements and SOW will incorporate additional reps and update safety attachment (resulting from recent enforcement actions and updates to CEPs from gov’t inspections). In addition to contract review and negotiations the successful 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 v. 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 Pfizer’s Compliance Program. The role will also 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. This position requires an individual who has extensive experience with pharmaceutical healthcare regulations including the anti-kickback statute and regulations and contract drafting and negotiation.
The position will report to the Assistant General Counsel, CSP Legal who supports the SAS COE. The role requires significant coordination with Pfizer Compliance colleagues, senior leaders, CSP Legal colleagues, and external parties such as outside counsel and third party vendors to address program requirements and reporting on specialty pharmacy interactions. The candidate will be skilled at 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 Pfizer.
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 Pfizer’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 Pfizer senior management and the Regulatory and Compliance Committee of the Board of Directors related to specialty pharmacy programs.
BS or BA degree required
JD (and admission to practice law in United States) required
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
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 required.
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.
Strong interpersonal skills to work with others within and outside the Company to identify and manage compliance risks are necessary.
Strategic, self-motivated, solution focused individual to identify compliance risk exposures and to develop mitigation strategies to address these risks. Candidate must be highly organized and focused on completion of tasks consistent with business objectives.
Position requires strong verbal and written skills, as well an ability to use Word, Excel and SharePoint systems to help manage work.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
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Other Job Details:
Last Date to Apply for Job: 2/9/2018
Eligible for Employee Referral Bonus
Internal Number: 4688861
Evolving to meet the needs of a changing societySince Pfizer was founded by cousins Charles Pfizer and Charles Erhart in 1849, our pharmaceutical company has remained dedicated to discovering and developing new, and better, ways to prevent and treat disease and improve the health and quality of life for people around the world. From the miracle of penicillin to patient assistance programs like Pfizer RxPathways that help people without prescription coverage have access to important medications, we focus on meeting the world’s diverse health needs. We invite you to explore our rich history and see how we have continually evolved our organization to keep pace with the needs and expectations of our stakeholders and society as a whole.