Counsel - Compliance Counsel Jobs in New_Jersey - 142517 | Submit Resume | General Counsel Consulting
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Melinda Burrows
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Energy Service Company
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Counsel - Compliance
Refer job# UKXU142517
 
Counsel - Compliance Duties: Provide legal counsel to global healthcare company on relevant issues involving application of U.S. law, regulations, and industry standards, primarily supporting the Ethics & Compliance Department. Acts as counsel for Ethics & Compliance Department and interacts with headquarters and other affiliates as required. May interact with government agencies, law firms, trade organizations and other external agencies. May provide guidance and training to less experienced professional and support staff. Reports to the Executive Director, Associate General Counsel, Clinical & Corporate Law. Serves as the single attorney primarily responsible for day-to-day legal support of the entire Ethics & Compliance Department including support for surveying the legal, regulatory and industry landscape for important trends and risks; developing new or improved policies and procedures and associated training; advising the monitoring and auditing functions; advising the Compliance Department on appropriate actions to take in response to findings from monitoring, auditing, investigations, hotline reports, etc.; advising on Compliance communications and program design; advising on all State and Federal compliance reporting requirements (e.g., Aggregate Spend and other transparency requirements).Keeps informed of new laws, regulations, and industry trends affecting the company, and assists with development of policies and training as needed. May draft or review NNI compliance policies, procedures, guidance documents, training material and other key documents. May retain, manage and assist outside counsel as needed. Performs other duties as assigned by senior management. Proactively identifies risks and mitigating actions. Provides legal support to with minimal oversight and guidance from managing attorney. Upholds, acts as a role-model for, and encourages other lawyers on the team to embrace the following approach to in-house counseling: Reliance on outside counsel is limited to only when necessary for unusual day-to-day issues. Ideally, there will be one lawyer per client or meeting (others may be consulted behind the scenes, but then only when necessary for narrow expertise). High levels of consistency in legal advice (actual and perceived by explaining differences to clients). Seek alignment up and across Legal, in advance of client meetings as much as reasonably possible. High levels of ownership, accountability and pride by lawyers with respect to their work. Actively seeking customer feedback on a continuous basis, actively listening and clarifying feedback, and acting in response as needed. Legal is viewed as a business partner and not an obstacle. Legal advice against engaging in a business practice is well-understood and respected by clients. Legal advice is clear as to the risk types, level, likelihood. Business-focused advice rather than abstract legal possibilities. Proactive, creative value-added legal role to help the business achieve its goals. Upholding and modeling ethical behavior and conduct at all times.

Qualifications: A JD Degree with 8+ years legal experience required; some in-house experience strongly preferred; experience within the branded pharmaceutical industry and active handling/responsibility for Compliance program issues is required; experience in handling and implementing a Corporate Integrity Agreement is highly preferred. A valid current State Bar admission and Good Standing required. Strong problem-solving skills-demonstrates and exercises creativity and initiative. Strong written and verbal communications skills-able to effectively collaborate and communicate with client groups within the company. Proactive, creative, innovative problem-solving and collaborative approach to counselling clients. Able to analyze business for multiple potential legal issues, including as applicable: Warning letter issues, off-label promotion, communications with Healthcare Professionals (HCPs), scientific exchange, press releases, publications, public presentations. Other Food and Drug Administration (FDA) law enforcement by Department of Justice (DOJ), States as to off-label promotion, etc. Other FDA law and regulations, governing drug development, clinical studies, GxPs, responding to 483s, Recall, Pharmacovigilence reporting, clinical holds, informed consent. Anti-Kickback (Federal and State). Products Liability. Federal Trade Commision (FTC) competition/competitor issues and risks. Consumer fraud. Practice of medicine. HIPAA and other data protection/collection issues. False Claims Act.
 
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This particular job is currently not active. However, since our clients regularly share with us similar and other job openings, we strongly recommend that you submit your resume. We shall review your resume and get in touch with you as soon as a suitable vacancy comes up to further discuss your interest in exploring the opportunity. Assisting you is our highest priority.

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