Senior Corporate Counsel - Compliance
- Job Title
- Senior Corporate Counsel - Compliance
- Job ID
- 27694368
- Work Hybrid
- Yes
- Location
- Boston, MA 02108
- Other Location
- Description
-
Description:
The Senior Corporate Counsel (“Corporate Counsel”) is responsible for advising on a variety of healthcare- related legal, regulatory and compliance issues governing on-market and pipeline products, with a primary focus on the Anti-Kickback Statute, False Claims Act and advertising and promotional regulations. The Corporate Counsel will report directly to the General Counsel/Chief Compliance Officer. The Corporate Counsel will work closely with senior management, other members of the legal department and other business departments, as needed.
The Corporate Counsel will manage and support daily activities relating to pharmaceutical compliance. The Corporate Counsel will be involved in the oversight and management of AVEO’s compliance and ethics program, ensuring that AVEO exercises due diligence and sound internal controls to operate with integrity and protect against legal risks. The Corporate Counsel will: (1) implement robust compliance policies and procedures to meet all regulatory standards and state and federal guidelines; (2) maintain, implement and manage all training on compliance-related subjects and processes; (3) monitor employee compliance with policies and procedures; (4) assist in investigations, as necessary; and (5) maintain and manage transparency reporting under the Sunshine Act and relevant state laws.
The Corporate Counsel will keep abreast and monitor all state and federal regulations affecting pharmaceutical personnel and report upcoming changes in federal and/or state laws. The Corporate Counsel will also review and draft legal documents and advise employees on legal and regulatory issues related to vendors, projects, and sales and marketing.
Key Responsibilities:
- Provide substantive advice to various departments including Commercial Sales Force, Marketing, Market Access, Medical Affairs and Regulatory Affairs departments concerning a broad range of legal, regulatory and compliance issues. These include FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, the Sunshine Act and competition law in connection with product labeling, promotional and non-promotional activities.
- Provide clear advice to business clients and senior legal management on U.S. laws focusing on areas of promotion, patient support, payor access, go-to-market strategies, and scientific exchange.
- Provide legal advice and assistance for the development of policies and training, and conduct training.
- Advise General Counsel of project developments in a timely manner. Execute core job responsibilities in a timely manner.
- Work cross-functionally and find solutions for business clients consistent with the law, policies/procedures, and the Company’s Code of Conduct.
- Provide subject matter expertise on a variety of agreements including: complex commercial agreements, third party vendor agreements, service agreements, pharmacy agreements, consulting agreements and other corporate agreements.
- Keep abreast of regulatory developments to identify the potential impact to AVEO’s business
- Identify potential areas of compliance risk and vulnerability, and help develop additional policies and procedures to help minimize that risk.
- Manage vendor and other third-party screenings to identify and mitigate potential corruption and other risks to the company.
- Assist with the development and delivery of compliance training programs.
- Conduct periodic legal reviews of the Company’s compliance program.
- Compile and analyze information from such legal reviews to propose revisions to compliance policies and procedures as needed.
- Help select and direct the work of outside counsel, define project objectives, manage project and budget, as needed.
- Perform other duties as assigned.
Qualifications:
Basic Qualifications:
- Juris Doctor (J.D.) or equivalent from an accredited law school and admission in good standing to a state bar.
- Minimum 6 years of relevant experience (combination of compliance-related in-house and/or law firm work experience).
- Experience with Market Access/Managed Health Care matters is desirable, but not required.
- Excellent client service and written/verbal communication skills required.
- High level of professionalism with strong judgment and commitment to ethical issues.
- Must be detail oriented with outstanding organizational skills and the proven ability to handle multiple responsibilities simultaneously while maintaining high quality and performance under pressure
- Ability to work independently and with a diverse set of personalities in a team environment.
- Results-driven, has a strong sense of urgency and is able to drive results.
- Business-minded and comfortable in an entrepreneurial, fast-paced environment where demands and priorities change rapidly.
- Able to effectively interact with, influence and collaborate with other members of the organization.
- Proven track record of learning quickly, taking initiative, working proactively, being resourceful, and taking on additional responsibility.
- 6+ years in the U.S. and International healthcare compliance experience.
- Experience with a senior compliance role in global cross-cultural and cross-functional teams, including implementation of global compliance programs.
- Project Management and System Implementation experience.
- High risk awareness and risk management skills.
AVEO Oncology (“AVEO”) is an oncology-focused biopharmaceutical company committed to providing innovative solutions to improve cancer patients lives. On January 20, 2023, AVEO was acquired by LG Chem, Ltd. (“LG Chem”), establishing a U.S. commercial presence for LG Chem and expanding LG Chem’s global oncology portfolio. AVEO continues to commercialize FOTIVDA® (tivozanib) in the U.S. To learn more about FOTIVDA efficacy, safety, and relevant resources, visit FOTIVDAHCP.com.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
