A well respected pharmaceutical company has a need for an Associate 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 be responsible for designing and managing a US Branded Healthcare Compliance program.
The responsibilities will include, regulation of clinical trials, human subject protection and manufacturing; and ensuring compliance with FDA regulations, PhRMA Code, government pricing requirements, the federal anti-kickback and false claims statutes, and the Patient Protection and Affordable Care Act.
Heavy emphasis on review and approval of advertising and promotional materials.
location: Princeton, New Jersey
job type: Permanent
salary: $130,000 - 150,000 per year
work hours: 8 to 5
education: Law Degree
experience: 3 Years
- Proactively identify emerging regulatory issues, developments in industry practices and standards and Compliance risk trends; and design appropriate policies and procedures to ensure continuing relevance of the Compliance Program.
- Determine the potential impact on the business and identify potential areas of compliance risk to ensure policy/procedure and/or enhancements are developed and implemented in order to manage identified risk areas effectively.
- Develop, initiate, maintain and revise simple, straightforward and practical policies and procedures for the operation of the US Healthcare Compliance Program.
- Ensure identification, engagement and management of relevant stakeholders across the organization during the development of policies and SOPs.
- Provide healthcare compliance subject matter expertise in the development of appropriate systems and working tools to support the Compliance Program requirements.
- Provide relevant input to raise awareness of Compliance related topics.
- Provide guidance on the Global Compliance Policy/SOP architecture, ensuring sufficient oversight and elaboration of consistent standards at Global level.
- Prepare Compliance related reports and presentations and other communications for employees and senior management.
- JD degree from an accredited law school is required.
- At least 3 years of related professional experience in the Pharmaceutical Industry.
- Knowledge of healthcare law, including general principles of Medicare reimbursement programs, anti-fraud statutes is also required.
- Knowledge of Sunshine Act/Open Payments requirements.
- Ability to interact well with people from various levels within the organization (including senior management) and across functional units (including commercial, clinical corporate and R&D) is required.
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.