Chief Compliance Officer and Legal Counsel Responsibilities: Developing a strong understanding of Company business needs to support Company's changing legal requirements and assist in designing and implementing Company policies and procedures to meet those requirements; Strong healthcare compliance background including review and approval for disease state education, pre- and post-approval communications, reprints, sponsorships and spokespersons, advertising and promotion, labelling, conference participation, and social media, DTC and website compliance; Drafts and negotiates regulatory terms and contracts on behalf of sponsors, applicants, application holders, and others, including clinical trial agreements, investigator-initiated study agreements, contract research organization (CRO) agreements, consulting agreements, quality agreements, safety data exchange/ pharmacovigilance agreements, and informed consent forms. Providing advice and counsel on the preparation of such agreements as well as the Company's rights and obligations under executed agreements; Counseling on appropriate relationships with healthcare professionals, patients, managed care entities, academic institutions, and government entities, including rebates, sponsorships, advisory committees, and education; Keeping apprised of applicable federal, state, and local laws and regulations and apply them to areas of responsibility including global privacy (GDPR), FCPA and anti-bribery.
Qualifications: JD degree. Admitted to at least one state bar. Admitted to California bar or admitted as Registered In-House Counsel in California is a plus. 5+ years of experience as in-house counsel in a biotechnology, pharma or healthcare company or a combination of in-house at large public company and/or nationally recognized law firm specializing in the area of interest. Prior experience leading the development and implementation corporate compliance program, including development and implementation of relevant policies, procedures, training and auditing and monitoring programs would be beneficial. In depth understanding of the legal and regulatory environment as it relates to healthcare compliance in the biopharmaceutical industry (e.g. anti-kickback statutes, government fraud & abuse, PhRMA Code, etc.). Detailed-oriented with a high level of intellectual, professional and interpersonal agility and flexibility, combined. An ability to operate independently. Excellent communication skills, both oral and written. Intellectual curiosity and a willingness to take responsibility for novel and emerging areas of regulation. Well-organized and hardworking, with the ability to manage numerous projects simultaneously under deadline pressure. Excellent analytical skills, with a strong ability to draft and review legal documents, analyze legal advice and apply legal advice to business needs. Ability to form strong working relationships with all levels of management, employees, and partners while maintaining firm adherence to proper legal standards. Team-oriented, sound judgment, self-motivation and willingness to take initiative.
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