A position to assist with contracting for Specialty Pharmacy adherence programs and with implementation of these service arrangements.
Implementation of the legal oversight of SPP interactions to ensure compliance; 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 coordinate with the SPP Lead counsel. The role requires significant coordination with Pfizer Compliance colleagues, senior leaders, Pricing and Access 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.
This is a legal role focusing on the United States.
- Assist in the structuring of Pfizer’s contractual relationships with specialty pharmacy providers in master services agreements (MSAs) and statements of work (SOWs).
- Review proposed customer engagement programs to support appropriate specialty pharmaceutical therapy adherence with attention to fair market value assessment, anti-kickback statute compliance, and safe harbor exceptions.
- Advise internal teams regarding design and operation of reimbursement support programs, considering fraud and abuse laws, state law considerations, and other legal framework impacting pharmaceutical manufacturers.
- Advise Pfizer patient assistance and Pfizer Biopharma brand teams regarding patient assistance programs in light of evolving state, federal law and OIG guidance, including, for example, program design, marketing and operations.
- Analyze and draft discount and rebate agreements for payers.
- Coordinate with Legal and Compliance colleagues to enhance policies and systems controls to address compliance risk areas; interpreting laws, regulations and policies relating to U.S. financial and other patient assistance engagements.
- Strong Leadership Skills and the ability to support Team Leaders within the organization
- Strong academic background, Bachelor’s Degree and Juris Doctorate or equivalent law degree
- 10+ years legal and/or compliance in the pharmaceutical or biotech industry, including experience in fraud and abuse, regulatory law and commercial/medical-related matters
- 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
- Demonstrated ability to grasp statutory and regulatory concepts quickly, and to proactively identify and analyze potential legal issues and provide thoughtful and creative business-focused legal advice and solutions
- Proven capacity to cultivate strong client relationships and successfully influence leadership in a fast-paced, innovative business climate
- A thorough understanding of regulatory and legal frameworks governing payer engagements and medical activities
- 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
- Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact
Nice To Have:
- 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