Director, Healthcare Compliance Business Partner

Director, Healthcare Compliance Business Partner

Location: Princeton, NJ

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Company Information

Our client is a global biotechnology company developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. They currently have three R&D sites around the world.

Overview

The Director, Healthcare Compliance Business Partner (HCBP) proactively collaborates with Commercial and Medical Affairs functions and the Compliance Officer (CO) to ensure healthcare compliance program development, administration, monitoring and enforcement for Commercial and Medical Affairs activities. The HCBP advises and provides training to Commercial and Medical Affairs colleagues on healthcare compliance related matters, monitors healthcare compliance activities and analyzes statistical data and reports to identify and determine the compliance issues related to the Commercial and Medical Affairs organizations. The HRBP also advises compliance leadership on carrying out policies related to healthcare compliance programs in accordance with federal and state regulations.

The HCBP executes the Compliance department auditing and monitoring program for Commercial and Medical Affairs functions, including supporting the CO in healthcare compliance program implementation by conducting risk assessments, executing annual compliance auditing and monitoring plan, drafting auditing and monitoring summary reports, and communicating findings to business leaders. The individual will be responsible for executing live and transactional compliance and auditing activities to help ensure adherence to company policies and procedures as well as compliance with law, regulation and codes. The scope of monitoring will span business activities, including Commercial and Medical Affairs and address key risk areas such as interactions with healthcare professionals, HCP engagements review, approval, tracking and monitoring (Needs Assessment process, i.e., Adboards) promotional practices, medical information, third party relationships, patient support services and government pricing.

Responsibilities

• Compliance Program Development
• Ensuring Compliance program processes and systems are in compliance with company policies, legal, regulatory and industry requirements

Compliance Advice

• Provide guidance to employees and third parties working on the client’s behalf on appropriate Commercial and Medical Affairs pre-launch and post-launch activities
• Advise on compliance policies, including interactions with HCPs, transparency, promotional activities, advisory boards, HCP meals, speaker programs, sales representative interactions, Medical Affairs.

Monitoring and Investigations

• Execute risk-based compliance monitoring programs across assigned business activities
• Conduct live observations of various programs and activities and sales representative ride-along
• Assist in conducting compliance investigations and corporate internal audits, as needed
• Develop and maintain monitoring dashboards and reporting tools and implement and manage systems, solutions and tools to enhance the effectiveness and efficiency of the monitoring program
• Track monitoring metrics, trends and observations and prepare periodic reports for presentation to management
• Ensure ongoing compliance through auditing and monitoring of pre and post-launch activities including advisory boards, site certification, Commercial and Medical interactions with HCPs and payers, sales and marketing activities, speaker programs and patient assistance programs
• Provide Compliance support to the MRC review process as needed, including as requested, reviewing advertising and promotional materials, training materials, press releases and similar internal and external communications.

Corrective Action Development

Assist with the identification, development and implementation of remediation and corrective action

Incorporate monitoring observations and trends into compliance policies, processes, training and communications

Risk Assessment Development

Contribute to the risk assessment process by identifying, evaluating and prioritizing risk areas, based on prior monitoring observations as well as existing and emerging risk areas

Training Development and Delivery

Develop and deliver relevant training to internal stakeholders and third parties

Requirements

• BS/BA degree required. Compliance certification preferred
• 8+ years with a pharmaceutical, biotechnology or other life sciences company in a healthcare compliance function role performing auditing, monitoring and development of compliance programs and advising internal clients on compliance matters
• Experience working in and leading cross-functional project teams
• Demonstrated experience as a compliance business partner having direct compliance experience with Marketing, Sales, Market Access, Medical Affairs, Legal, Regulatory and Communications
• Experience reviewing and advising on pre-and post-launch commercialization and medical activities and monitoring advisory boards preferred
• Excellent organizational, analytical and communication skills with the ability to support internal stakeholders at all levels
• Team player with ability to manage projects independently
• Demonstrated understanding of FDA regulations, including advertising and promotional regulations for pharmaceutical products, fraud and abuse laws and regulations, including the U.S. Anti-Kickback Statute, the U.S. False Claims Act, federal and state HCP transparency laws and regulations and industry standards relevant to the biotechnology and pharmaceutical industry, including the PhRMA Code and ICMJE
• Client offers a competitive salary package that is dependent on qualifications and experience as well as a strong benefit package, plus participation in a companywide bonus plan. Interested candidates should submit current resume. For a faster response please include job title in subject line. Please note that all candidates applying must have proper US work authorization, client will NOT sponsor.

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