- Develops and implements monitoring plan to ensure that compliance policies and procedures are followed, with the monitoring plan consisting of live field monitoring and document reviews.
- Assesses compliance and operational risks to helps develop risk management strategies.
- Assists in the development, design and implementation of compliance training throughout the company.
- Legal representative of MLR committee. Provides timely legal review of all materials submitted for MLR Review. Works closely with Commercial, Medical and Regulatory Affairs colleagues.
- Provides legal advice and counseling on various issues, including but not limited to Food & Drug Administration (FDA) labeling, marketing strategies, promotional tactics and materials, direct-to-consumer advertising campaigns and programs, patient support programs, customer interactions, healthcare professional (HCP) engagements, and commercial sponsorships.
- Proactively identifies risks, opportunities and mitigating actions, and collaborates across business functions to implement.
- Works closely with leadership from line of business in developing strategy and achieving objectives.
- Partners with the Chief Compliance Officer to implement an effective ethics and compliance program.
- Stays informed of new laws, regulations, and industry trends affecting the company, and assists with development of policies and training as needed.
- Performs other duties as needed or assigned.
What is Required:
- Juris Doctorate Degree ABA accredited law school and must be active member of the California State Bar or qualified as Registered In-house Counsel in either State.
- Minimum of 6+ years of relevant legal experience required.
- Experience within the healthcare/pharmaceutical industry is required.
- Knowledge and understanding of pharmaceutical compliance issues and ability to act independently on compliance related matters.
- Extensive knowledge and understanding of laws and regulations applicable to the biopharmaceutical industry, including but not limited to OIG Guidance for Pharmaceutical Manufacturers, PhRMA Code on Interactions with Healthcare Professionals, and the Foreign Corrupt Practices Act
- Litigation or Government Investigation experience is preferred.
- Strong problem-solving skills – demonstrates and exercises creativity and initiative.
- Ability to gain trust at, and work with, all levels of organization.
- High level of integrity with the ability to maintain the protection of proprietary and confidential information
- Strong written and verbal communications skills – able to effectively collaborate and communicate with client groups, senior management and executives within the company.
- Ability to handle multiple projects simultaneously independently.