Chief Compliance & Regulatory Counsel — Pharma

Page Mechanical Group, Inc.; Boston (MA); On-site; USD 210,000 - 320,000; Full time

Job summary

AVEO Oncology in Boston, MA seeks a Vice President, Compliance & Regulatory Counsel to lead complex healthcare regulatory matters, advise senior management, and oversee the company’s compliance program. The role requires extensive experience in FDA regulations, False Claims Act, and Sunshine Act, with collaboration across commercial, medical and regulatory teams.

The incumbent will manage policy development, training, external counsel, and risk assessments while guiding governance and ethical

Qualifications

• Juris Doctor (J.D.) 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.
• Possess significant expertise in all areas of U.S. laws and regulations including FDA, anti kickback, antitrust, privacy and product liability.
• Experience in working with Market Access/Managed Health Care matters is desirable.
• 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‑mindled 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.

Responsibilities

• Provide clear and substantive advice to senior management and business clients on a broad range of legal, regulatory and compliance issues focusing on promotion, patient support, payor access, go-to-market strategies, and scientific exchange.
• 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.
• Collaborate with R&D and IP colleagues involved with late-stage clinical and marketed products with responsibility for ensuring an aligned approach across multiple products.
• 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.

Skills

Regulatory compliance

Legal guidance

Communication skills

Cross-functional collaboration

Project management

Education

Juris Doctor (J.D.) or equivalent

Job description

AVEO Oncology in Boston, MA seeks a Vice President, Compliance & Regulatory Counsel to lead complex healthcare regulatory matters, advise senior management, and oversee the company’s compliance program. The role requires extensive experience in FDA regulations, False Claims Act, and Sunshine Act, with collaboration across commercial, medical and regulatory teams.

The incumbent will manage policy development, training, external counsel, and risk assessments while guiding governance and ethical