Counsel Law and Compliance

Job Title Vice President, Compliance & Regulatory Counsel

Reports To Senior Vice President, General Counsel

Summary The Compliance & Regulatory 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 Compliance & Regulatory Counsel will work closely with senior management, members of the legal department and other business departments, as needed. The Compliance & Regulatory Counsel will report directly to the General Counsel and serve as the Chief Compliance Officer. The Compliance & Regulatory Counsel will manage and support daily activities relating to pharmaceutical compliance. The Compliance & Regulatory 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.

Implement robust compliance policies and procedures to meet all regulatory standards and state and federal guidelines.

Maintain, implement and manage all training on compliance-related subjects and processes.

Monitor employee compliance with policies and procedures.

Maintain and manage transparency reporting under the Sunshine Act and relevant state laws.

The Compliance & Regulatory Counsel will keep abreast and monitor all state and federal regulations affecting the pharmaceutical industry and report upcoming changes in federal and/or state laws. The Compliance & Regulatory Counsel will also review and draft legal documents and advise employees on legal and regulatory issues related to vendors, projects, and sales and marketing.

Principal Duties Provide clear and substantive advice to senior management and business clients(Commercial Sales Force, Marketing, Market Access, Medical Affairs and Regulatory Affairs departments) on a broad range of legal, regulatory and compliance issues focusing on areas of promotion, patient support, payor access, go-to-market strategies, and scientific exchange. 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.

Advise cross-functional teams including clinical, product development, regulatory, medical affairs, and other clients on FDA regulatory submissions, label negotiations and privacy and data use. Provide counsel on appropriate relationships with a variety of external parties including healthcare professionals, patients, academic institutions, and payors.

Review business materials (including brand plans, promotions, medical plans and training documents) requiring legal input and advising internal clients, partners and stakeholders on compliant strategies, plans and tactics.

Provide legal advice and assistance for the development of policies and training, and conducts training.

Advise the General Counsel of project developments in a timely manner.

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 vendors 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.

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.

Partner with Commercial, Medical Affairs, Market Access, Regulatory Affairs, and Clinical Development to provide practical legal and compliance guidance.

Support compliance risk assessments and recommend solutions to mitigate identified risks.

Support compliance monitoring, auditing, and corrective action initiatives to strengthen the compliance program.

Provide legal and compliance guidance regarding healthcare professional (HCP) engagements, including advisory boards, consulting arrangements, and speaker programs.

Serve as the Legal representative on the Material Review Committee (MRC), providing legal and regulatory guidance for promotional and medical review activities.

Support compliance initiatives, regulatory inquiries, audits, and other cross-functional projects, as needed.

Contribute to the development of AVEO’s compliance focused culture.

or equivalent from an accredited law school and admission in good standing to a state bar.

Minimum of 10+ years of relevant experience (combination of compliance-related inhouse and/or law firm work experience).

Experience in providing legal expertise/guidance to product development and strategy. Experience supporting a pharmaceutical commercialized brand required.

Experience with leading educational sessions regarding compliance and branding for senior leadership, key stakeholders, the legal team and the company.

Experience in providing an enterprise view in developing and delivering legal guidance to internal stakeholders.

S. laws and regulations including FDA, anti kickback, antitrust, privacy and product liability.

Experience with working on Market Access/Managed Health Care matters is desirable.

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

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.

About AVEO About AVEO AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company. 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.