A well respected pharmaceutical company has a need for a Director - Healthcare Compliance Legal Counsel.
Work will be remote to start, but will resume in office in Princeton, NJ, so you must be able to work onsite when the COVID-19 situation settles down.
This individual will will work with management in regards to the oversight of the Company's Healthcare Compliance Program, with significant interaction with Sales and Marketing, Legal, Information Technology, Medical Scientific Affairs, Regulatory Affairs, and other company departments.
location: Princeton, New Jersey
job type: Permanent
salary: $165,000 - 180,000 per year
work hours: 8 to 5
education: Law Degree
experience: 8 Years
- Partner with company departments to maintain a company culture that embraces compliance and recognizes that compliance is a collective responsibility of all company employees
- Increase awareness of the importance of the healthcare compliance program, and maintaining and expanding visibility of the healthcare compliance program throughout the organization; provide general guidance to the business and integrate compliance controls into the scope of existing business practices company-wide
- Develop, implement, maintain and regularly assess key policies and procedures to mitigate identified risks and to meet government, industry and company healthcare compliance requirements
- Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including federal and state fraud and abuse and anti-kickback statutes, government price reporting laws, OIG and PhRMA guidelines, state marketing compliance laws
- Provide oversight and guidance to department members regarding obligations and submissions federal and state authorities regarding applicable transparency ("Sunshine") laws
- Develop, maintain, enhance and administer effective compliance training programs through various delivery formats that focus on the elements of the compliance program and seek to ensure that appropriate employees understand, and understand the importance of compliance with, pertinent requirements
- Collaborate with Company management and other personnel to identify and provide ongoing risk assessment of existing and emerging business practices for potential areas of compliance vulnerability, and develop/implement preventive active plans to help maintain compliance, and where necessary develop and implements corrective action plans for the resolution of issues
- Provide regular updates and reports to the Chief Compliance Officer, the Compliance Committee, and senior and executive management on the operation and progress of compliance efforts and initiatives, audit findings, investigation outcomes, and project status updates
- Oversee and implement compliance-related auditing and monitoring plans for sales, marketing and other business activities
- Assist in management of compliance investigations involving potential violations of compliance policies, laws or regulations and overseeing corrective action
- Serve as a subject matter expert in areas of healthcare regulatory law, including rules and regulations of the FDA, OIG and CMS and applicable anti-kickback, fraud and abuse, and statutes and regulations
- Oversee review of sales training materials, corporate communications, and manage market access initiatives and patient assistance programs.
- Provide advice on market access initiatives and patient assistance programs;
- An active license to practice law in NJ.
- Expertise in the area of pharmaceutical industry healthcare compliance with a proven record of accomplishment in the areas of drafting and implementing compliance policies, training, auditing, monitoring, and investigations;
- Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry including federal and state government price reporting laws, fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines, state marketing compliance laws
- Expertise in commercial healthcare, and FDA regulatory law and regulations, including expertise in FDA labeling and promotional requirements, healthcare fraud and abuse laws, and other laws and regulations related to the sales and marketing of pharmaceutical products;
- Admitted to practice law in one or more states.
- 8 + years of pharmaceutical company compliance experience;
- Ability to work in a fast-paced environment and to handle multiple complex and confidential tasks
skills: Healthcare Law, Compliance Law
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.