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Corporate Counsel, Executive Director
Refer job# IWVI157600
Corporate Counsel, Executive Director Duties: Partner with senior management and various corporate functions (e.g., Business Development, Commercial, and Medical Affairs) to provide pragmatic legal advice, assess risk, and to design and implement legal strategy that aligns with business goals. Collaborate on business development and financing transactions; lead legal due diligence activities; and draft, review and negotiate deal-related documents. Oversee cross-functional efforts to develop, implement monitor and improve policies and procedures, and train employees regarding, compliance with applicable Fraud & Abuse laws, public company compliance and privacy. Advise key stakeholders on laws and regulations governing the research, development, promotion and sale of pharmaceutical products, including US FDA regulations, government price reporting obligations, the Anti-Kickback Statute, False Claims Act, HIPAA, GDPR and other privacy laws as well as the Foreign Corrupt Practices Act. Maintain an understanding of applicable healthcare laws, regulations, and enforcement actions to identify emerging risks and advise management and other stakeholders as needed. Draft, review and negotiate commercial and corporate contracts. Strong technical/analytical skills, combined with a practical, balanced, business-oriented and strategic approach to identifying and solving business and legal problems.

Qualifications: JD Degree with excellent academic credentials. Member in good standing of the Massachusetts Bar or another bar in the U.S. 10+ years of industry-related experience with a demonstrated in-depth understanding of the operation of multiple functions in biopharmaceutical organizations and the applicable legal and regulatory framework. Prior experience working in a law firm also a plus although not required. Significant legal experience drafting, reviewing and negotiating transaction, operations and/or commercial agreements for biotechnology clients. Strong negotiation, communication, administrative and time management skills. Knowledgeable of the laws and regulations affecting the biologics and pharmaceutical industry. Ability to evaluate effectively legal exposure, manage risk and develop creative, client-focused solutions to achieve business goals within appropriate legal guidelines. The preferred candidate will have worked at a leading U.S. national law firm and had an in-house counsel position with a biotech/pharmaceutical company. Significant experience with healthcare compliance counseling, with a working understanding of OIG guidance, applicable regulations and laws relating to the development, sales and marketing of pharmaceutical products, and the U.S. DOJ, state and FDA enforcement landscape. Excellent oral and written communication skills are essential. Entrepreneurial with the ability to work well independently as well as collaboratively in a team environment. Must have excellent judgment with the ability to assess risks and benefits (determining what risks are acceptable) and determine the best path to achieving desired results.

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