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Corporate Counsel Associate Director/Director Legal Compliance

Boulder CO Corporate Counsel - Associate Director/Director Legal Compliance Responsibilities: Providing advice, education, training and legal direction on FDA labeling and promotional matters, healthcare fraud and abuse laws, product liability, antitrust, privacy and other laws impacting the commercialization of biotech products; Serving as a standing or ad hoc member of business or leadership teams and providing legal counsel and expertise into business decisions; Advising on business strategies, tactical plan development and implementation, and other business issues, including development of legal assessments and solutions-oriented risk mitigation strategies; Reviewing business materials (including brand plans, promotions, medical plans, training documents) requiring legal input and advises internal clients, partners and stakeholders on compliant strategies, plans and tactics; Advising clinical, product development, regulatory, medical affairs, and other clients on FDA regulatory submissions, label negotiations and privacy and data use; Counseling on appropriate relationships with healthcare professionals, patients, managed care entities, academic institutions, and government entities; Developing and implementing training to internal clients, partners and stakeholders on key policies, procedures, practices and requirements for healthcare and related legal compliance; Educating clients and partners about current enforcement trends; Director level: may provide guidance and direction to other members of the legal and compliance team.

Qualifications: JD degree from an accredited law school. Must be licensed to practice law in 1 state and in good standing. Excellent academic and law firm credentials. Must have 3-6 (Associate Director) / 7-9 years (Director) of relevant legal experience related to the promotion and clinical development of therapeutics at a law firm with a nationally recognized Life Sciences/Pharma/Biotech practice or in-house at a pharma/biotech organization. Science background a plus. Significant knowledge of enforcement trends, the Federal Food, Drug and Cosmetic Act and related regulations, the False Claims Act, and laws related to fraud and abuse in the pharmaceutical and biotech industries is required. Excellent skills in verbal and written communication, with a demonstrated ability to deliver sound and concise legal advice in a solution-oriented manner and in the context of evolving business strategy. Strong organizational skills in order to prioritize and manage multiple time-sensitive projects simultaneously; willingness to assume heavy workload to meet timing and project needs. Ability to collaborate, as well as work independently, balancing competing priorities. Strong client-support skills Attention to detail. High business acumen with the ability to appropriately balance legal and business risks in an ethical and compliant manner.
Legal 3 - 9 Full-time 2018-07-11
Locations (hold down ctrl to chose multiple): Primary Area of Practice:
All USA Locations
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1
 
Corporate Counsel Associate Director/Director Legal Compliance
Refer job# AAQX139917
 
Corporate Counsel - Associate Director/Director Legal Compliance Responsibilities: Providing advice, education, training and legal direction on FDA labeling and promotional matters, healthcare fraud and abuse laws, product liability, antitrust, privacy and other laws impacting the commercialization of biotech products; Serving as a standing or ad hoc member of business or leadership teams and providing legal counsel and expertise into business decisions; Advising on business strategies, tactical plan development and implementation, and other business issues, including development of legal assessments and solutions-oriented risk mitigation strategies; Reviewing business materials (including brand plans, promotions, medical plans, training documents) requiring legal input and advises internal clients, partners and stakeholders on compliant strategies, plans and tactics; Advising clinical, product development, regulatory, medical affairs, and other clients on FDA regulatory submissions, label negotiations and privacy and data use; Counseling on appropriate relationships with healthcare professionals, patients, managed care entities, academic institutions, and government entities; Developing and implementing training to internal clients, partners and stakeholders on key policies, procedures, practices and requirements for healthcare and related legal compliance; Educating clients and partners about current enforcement trends; Director level: may provide guidance and direction to other members of the legal and compliance team.

Qualifications: JD degree from an accredited law school. Must be licensed to practice law in 1 state and in good standing. Excellent academic and law firm credentials. Must have 3-6 (Associate Director) / 7-9 years (Director) of relevant legal experience related to the promotion and clinical development of therapeutics at a law firm with a nationally recognized Life Sciences/Pharma/Biotech practice or in-house at a pharma/biotech organization. Science background a plus. Significant knowledge of enforcement trends, the Federal Food, Drug and Cosmetic Act and related regulations, the False Claims Act, and laws related to fraud and abuse in the pharmaceutical and biotech industries is required. Excellent skills in verbal and written communication, with a demonstrated ability to deliver sound and concise legal advice in a solution-oriented manner and in the context of evolving business strategy. Strong organizational skills in order to prioritize and manage multiple time-sensitive projects simultaneously; willingness to assume heavy workload to meet timing and project needs. Ability to collaborate, as well as work independently, balancing competing priorities. Strong client-support skills Attention to detail. High business acumen with the ability to appropriately balance legal and business risks in an ethical and compliant manner.
 
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