This position supports the compliance function and will be responsible for assisting in the development, execution and continuous improvement of the compliance program to ensure compliance with all applicable standards, laws, and regulations, including without limitation the U.S. Anti-Kickback Statutes, the False Claims Act, the Stark Laws, the Sunshine Act (Open Payments), the FCPA and HIPAA. This position will support the Chief Compliance Officer with respect to commercial legal and compliance matters and activities as well as other Legal projects as needed.
ESSENTIAL DUTIES & RESPONSIBILITIES:
- Monitors activity to help ensure compliance with PhRMA Code with respect to HCP interactions
- Provide advice and training to employees of the Company on the health care compliance program using a solid understanding of U.S. pharmaceutical laws, including regulatory and compliance issues and laws pertaining to interactions with healthcare providers
- Provide legal support for wide range of commercial and medical affairs activities related to product launch and ongoing promotion of pharmaceutical products
- Provide legal guidance to Promotional Review Committee
- Provide legal guidance to Medical Review Committee
- Provide legal guidance to Grants Committee
- Stay current on applicable law, regulation, and practice and communicating senior management apprised of current developments
- Minimum of 3-5 years relevant commercial compliance experience, including prior in-house experience with a biotech/pharmaceutical company
- BA/BS degree and JD required
- A solid understanding of U.S. pharmaceutical laws, including regulatory and compliance issues
- A solid understanding of laws pertaining to interactions with healthcare providers (Anti-Kickback, False Claims etc.)
- Ability to handle highly confidential and sensitive materials and information with complete discretion
- Ability to provide commercial contracting support also strongly preferred
- Ability to work with external counsel, vendors and business partners
- Ability to work within a very small legal/compliance department, and establish and maintain relationships across multiple corporate functions
- Adaptable and flexible, able to prioritize duties and manage multiple matters from start to finish with minimal supervision
- Exceptional attention to detail and excellent organizational skills and the ability to work on a variety of tasks and projects simultaneously with minimal supervision.
- Ability to work cooperatively and collaboratively with all functions and levels of the Company
- Proven ability to communicate effectively in a variety of difficult and sensitive situations
- Ability to thrive in a dynamic and past-paced environment
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.
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