Executive Director, Lead Franchise Counsel - Hematology / Oncology Counsel Jobs in California - 162126 | Submit Resume | General Counsel Consulting
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Executive Director, Lead Franchise Counsel - Hematology / Oncology
Refer job# ZZLC162126
 
Executive Director, Lead Franchise Counsel - Hematology / Oncology Duties: Provides strategic, operational, and tactical legal and business insight on the regulatory approval and commercialization of hematology/oncology products including the launch of the Company's product candidates in North America. Provide legal advice and counsel related to the development of regulatory and business strategies related to the development and commercialization of the Company's product candidates and marketed products. Review and advise on strategies, programs, initiatives, contracts, policies, and training related to sales, marketing, medical, and other non-promotional education and scientific exchange. Review and advise on promotional materials, field training materials, product and disease-related communications, and health economics materials. Serve as a subject matter expert in the areas of US healthcare law and all applicable pharmaceutical marketing, anti-kickback, privacy, fraud and abuse, anti-bribery, Sunshine Act, and product liability statutes and regulations. Identify training needs within the organization; develop and present training sessions on relevant laws and legal/business issues. Stay abreast of and communicate to the organization all significant pending and actual decisions, legislation, and regulatory rulings that may affect the company in the area of commercial healthcare law. Closely coordinate risk assessment, investigation, training, and update activities with the Company's compliance personnel.

Qualifications: U.S. Juris Doctorate (J.D.) Degree. Active Law License in at least one U.S. Jurisdiction. 10 + years combined experience in-house and with a national law firm. Strong understanding of and experience with laws and regulations, legal and contractual principles, and intellectual property matters applicable to commercial activities of pharmaceutical companies within the United States. Demonstrated familiarity with the broader legal issues facing pharmaceutical companies internationally. Experience in working with the pharmaceutical or biotech industry. Experience leading a team is preferred. Knowledge of and proficiency with laws and regulations applicable to global pharmaceutical companies, including among other things, the US Foreign Corrupt Practices Act, US fraud and abuse and false claims laws, and PhRMA Code on Interactions with Healthcare Professionals. Excellent communication skills, both oral and written; ability to lead teams; ability to handle the heavy workload for multiple clients; team player with strong interpersonal skills. Strong interpersonal and oral and written communication skills. Able to innovate, analyze and solve problems with minimal supervisory input, anticipating and identifying legal and other business risks and making recommendations to management, as appropriate. Solid understanding of business goals and legal and regulatory landscape. High degree of personal, professional, and corporate ethics, integrity, and responsibility. Consistently shows initiative, and is willing and able to take high levels of responsibility for complex initiatives. Flexibility and is open to change in a growing, multi-cultural environment. Team player, able to work well with others and communicate with cross-functional colleagues and senior leadership. Capable of strategic thinking and proposing innovative solutions to compliance-related challenges. Ability to build, manage and/or develop a high-performing team. Comfortable in a results-driven, highly accountable environment where you can make a clear impact; strong motivation and ability to champion a comprehensive compliance program that is integrated well with the company's business and culture. A collaborator who communicates in an open, clear, complete, timely, and consistent manner.
 
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