The Commercial Solutions Platform Team is looking to fill a Corporate Counsel position to assist with contracting for Pfizer Innovative Health brand and Pfizer Essential Health Patient branded aspects of HUB (organizations that assist patients with access and reimbursement for Pfizer medications) interactions with the field account management teams and field based reimbursement teams or other ancillary roles that interact with patients or patient advocacy groups within the rare disease space. The individual will assist with contracting for and implementation of HUB vendors for brand funded activities e.g., portal development, eSignature capabilities, text messaging and/or integration with field based roles, plus assisting with review and implementation of Program business rules/rules of engagement guidance and compliance with such business rules; assist with trade distribution agreement preparations/implementation; and assist with government price reporting for various federal price reporting metrics. In addition to contract review and negotiations the successful candidate will assist with implementation of the legal oversight of HUB, and interaction with such Programs amongst brands and with implementation/integration with field sales/account management with respect to such programs. Integrate with Corporate Affairs and SAS COE clients to support appropriate operations with respect to brand funded HUB, programs and ensure compliance with the recommendations from recent settlements and with 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 brand funding of such Programs and internal policies and procedures to satisfy evolving industry and regulatory compliance requirements within the space in the US. With respect to trade distribution agreements, the individual will need a working knowledge of the differences amongst the various drug distribution channels, e.g., full line vs. specialty distribution and the buy and sell side dynamics of wholesalers and distributors and the various business lines that these customers are engaged. This position requires an individual who has extensive experience with pharmaceutical healthcare regulations including the anti-kickback statute and regulations, SOX compliance and contract drafting and negotiation.
The position will report to the Assistant General Counsel, CSP Legal who participates in negotiating and drafting agreements for brand funding of HUB vendors and integration with field based sales, account management and reimbursement support. The role requires significant coordination with Pfizer Compliance colleagues, senior leaders, CSP Legal colleagues, business team leaders within the U.S. Trade Organization and external parties such as outside counsel and third party vendors to address program requirements and reporting on HUB 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/managers and field sales colleagues.
Expand enterprise legal support to implement additional controls and oversight in the area of brand funding of HUB activities.
Draft and revise contractual provisions and implement brand funded HUB activities, such as portal development, eSignature capabilities, text messaging and/or integration with field based roles, plus assisting with review and implementation of appropriate Program business rules and compliance with such business rules for the above activities and assist with enhancement of corporate policy updates, including training and monitoring.
Support all aspects of marketing and operations with respect to such brand-funded HUB activities.
Provide centralized review and coordination of brand funded HUB activities with those supported by other team members within CSP Legal that support other HUB and reimbursement activities.
Provide counsel and implementation support for legal updates for government funded healthcare programs and price reporting metrics along with other CSP Legal colleagues.
Support Specialty Access Solutions Center of Excellence with implementation of compliance monitoring and periodic training on evolving issues within the product access space. .
Prepare and manage preparation of rules of engagement documents and reports on brand-funded HUB activities and integration with field based sales/account management or other ancillary roles that interact with patients or patient advocacy groups within the rare disease space, and participate in activities related to oversight of the Compliance Program as it related to brand funded HUB activities and the rules of engagement with such HUBs by sales/account management or other ancillary roles that interact with patients or patient advocacy groups within the rare disease space .
Assist with brand funded HUB program activities, systems, controls and reporting on such 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 HUB vendor personnel who are performing services for and on behalf of Pfizer.
Advise on the applicability of federal healthcare regulatory requirements and implications on business activities.
Develop and present training related to HUB interactions with sales/account management or other ancillary roles that interact with patients or patient advocacy groups within the rare disease space.
Coordinate with Legal and Compliance colleagues to enhance policies and systems controls to address compliance risk areas; interpreting laws, regulations and policies relating to brand-funded HUB activities.
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 brand-funded HUB activities.
Partner with Compliance to comply with imminent obligations.
Provide enhanced oversight, monitoring, SOP development, training related to brand funded HUB activities.
Support certification and RAMP process related to brand funded HUB activities.
Provide input and expertise to IRO related to brand funded HUB activities.
Assist with implementation of changes in regulations in Medicaid, Medicare, 340B and other government programs that are creating complex government price reporting obligations.
Work with the trade business colleagues to draft, negotiate and implement distribution agreements with wholesalers and distributors for the PIH and PEH business units.
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 and government price reporting
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 government price reporting under various Medicaid, Medicare, 340B programs, 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.
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
Other Job Details:
Last Date to Apply for Job: 2/9/2018
Eligible for Employee Referral Bonus
Internal Number: 4688859
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.