Counsel II / Compliance & Ethics Responsibilities: Provide global compliance and ethics advice and guidance to the Deputy and Chief Compliance Officers and to the Company's biopharmaceutical clinical research and commercial healthcare lines of business and corporate units regarding the company's Code of Business Conduct and Ethics (Code), corporate compliance and ethics policies and standards and other compliance and ethics issues or inquiries. Conduct global compliance and ethics investigations to ensure that investigations are conducted in a timely and comprehensive manner and that effective corrective action is implemented in accordance with the company's Code, corporate compliance and ethics policies and operating standards. Engage and collaborate with key stakeholders (e.g., human resources, internal audit, quality, business management and senior leadership, etc.) to ensure the company's Code and corporate compliance and ethics program policies and operating standards are developed and/or updated, implemented appropriately and enforced consistently. Interact with and advise business leaders on compliance and ethics issues that affect the success of the company and the execution of the Company's strategic business priorities. Assist in the development and implementation of global compliance and ethics policies, governance and oversight processes, and controls and strategies. Assist in the development and implementation of risk assessments, including the global anti-bribery/anti-corruption risk assessment program. Monitor global legal and regulatory changes that have the potential to affect the Company and assist with identifying any necessary changes to the compliance and ethics program and/or business operations based on legal or regulatory changes or identified emerging risks. Deliver targeted compliance and ethics training and education to the Company's business and corporate units.
Qualifications: Law degree from an accredited law school; licensed to practice law in at least one jurisdiction. Industry experience in a healthcare or life sciences company, such as a CRO, biotech, or pharmaceutical drug development and/or medical device company is preferred. Experienced attorney with years of relevant experience, including pharmaceutical healthcare compliance experience that includes providing legal and/or compliance advice and guidance related to the sale and marketing of pharmaceutical products and clinical research and development. Substantive working knowledge of US Federal and state laws and regulations that apply to the pharmaceutical, biotechnology, or medical device industry, including Federal healthcare program requirements under the Food, Drug and Cosmetic Act ( FDCA ), the Prescription Drug Marketing Act, False Claims Act, the Anti-Kickback Statute, the Transparency Provisions of the Patient Protection and Affordable Care Act (the Sunshine Act ), the Foreign Corrupt Practices Act ( FCPA ) and U.S trade sanctions laws. Experience conducting investigations, preferably in the pharmaceutical/medical device industries, including experience in investigations related to the sales and marketing of pharmaceuticals and medical devices. Substantive working knowledge of the U.S. Federal Sentencing Guidelines and other governmental requirements and standards for implementing effective compliance and ethics programs. Exceptional writing and analytical skills, independent judgment, a desire to learn, and an ability to take on and prioritize a wide variety of complex compliance and ethics matters. Proactive, highly responsive, able to handle confidential or sensitive information in a professional and appropriate manner, and to manage the expectations of a dynamic, global business environment. Outstanding communication, relationship-building and influencer skills with senior and executive business leaders. High level of business acumen. Ability to work independently while being able to contribute successfully to cross-functional teams. Ability to collaborate with colleagues and take a business-oriented approach while identifying and balancing risks and providing succinct, accurate and pragmatic advice. Independent judgment, attention to detail, a desire to learn, and an ability to take on and prioritize a wide variety of complex matters while meeting tight deadlines. Collegial can-do attitude and ability to work under pressure and manage the expectations of clients. Creative problem-solving ability with a focus on achieving client-friendly solutions while managing company risk.
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