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Associate Counsel And Director Of Compliance
Refer job# CXLT159171
 
Associate Counsel and Director of Compliance Duties: Provide high quality legal advice and serve as a trusted strategic partner to a variety of internal teams in a way that advances business while addressing legal risks and protecting the company's integrity and reputation; Manage and oversee the Company's Compliance Program; provide training and guidance to employees on the Company's policies and procedures; Manage and oversee outside counsel on a variety of projects; Draft, negotiate, and finalize a variety of legal agreements including, but not limited to, commercial contracts with customer and distributor, vendor agreements, non-disclosure agreements, development, manufacturing and service agreements, quality agreements and clinical trial and research agreements, and provide post-execution advice and counsel to internal clients on contractual obligations; work closely with the Contracts Manager in overseeing the contracts lifecycle; Manage and oversee the Enterprise Risk Management Program; Assist in legal due diligence initiatives relating to potential transactions; Monitors the external regulatory and enforcement environment to identify risks to the Company and its customer relationships, day-to-day counseling and training of Company's functional groups; Partners with Regulatory Affairs/Quality Assurance teams to assist and counsel in developing policies, procedures, product manuals, legal guidance documents, tools and training materials; Oversee the Company's state pharmaceutical manufacturer, wholesaler and distributor licenses; Provides advice and counsel on various sales and marketing as well as other materials for dissemination relating to the Company and its potential products, as well as respond to requests from the RA/QA teams for reviewing product labeling and liability questions. Assist in developing global IP portfolio and support research and development teams to identify and protect new IP opportunities using outside counsel; Oversee and support outside counsel on litigation matters; Assist on all other matters, as required by the Company.

Qualifications: JD Degree from an accredited law school; admitted into practice and in good standing in at least one state. 4 - 7 years of experience is required, ideally supporting the life sciences industry in a law firm setting or as a member of a legal department in a pharmaceutical/biotech company. Strong drafting and communication skills, and an ability to maintain a high level of attention to detail. Commitment to client service, finding solutions, relationship building, continued learning, proactivity and confidentiality. General understanding of the concepts, terminology and interdependencies that are important in the research-based pharmaceutical industry, including with respect to intellectual property rights. .Excellent interpersonal skills. Ability to manage and prioritize multiple matters simultaneously and respond to rapidly shifting priorities in ambiguous or challenging situations. Demonstrated ability to own projects and consistently meet tight timing requirements and high-quality standards. Strong verbal and written communication skills. Ability to handle confidential and proprietary information using impeccable discretion and judgment.
 
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