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Associate General Counsel (Executive Director)

Company: Arcutis Biotherapeutics, Inc.
Location: Anaheim
Posted on: July 28, 2022

Job Description:

Job Summary The Associate General Counsel (Executive Director), Healthcare Law, will help form and work in the Healthcare Law Team within Arcutis' Legal Department. The position will have the opportunity to provide legal advice and support across the lifecycle of Arcutis' products, including commercial, medical affairs, and market access, both domestically and globally. Supported teams include product sales and marketing, commercial strategic and operational functions, regulatory, market access (patient access, pricing, contracting and distribution), clinical research, medical affairs, as well as business development and corporate alliances. Roles & Responsibilities Providing advice, education, training and legal direction on, healthcare fraud and abuse laws, pricing, FDA labeling and promotional matters, clinical research, healthcare compliance, products liability, antitrust, privacy and other laws impacting the commercialization of biotech products; Serving as lead legal counsel for product lifecycle and cross-functional product teams and initiatives, and participating in several committees, such as the pricing committee and the Arcutis material review committee; Advising on business strategies, tactical plan development and implementation, and other business issues, including development of legal assessments and solutions-oriented risk mitigation strategies; Advising regulatory, medical affairs, and other clients on FDA regulatory submissions, label negotiations and privacy and data use; Counseling on appropriate relationships with healthcare professionals, clinics and societies, patients and advocacy organizations, organized customers, and government entities; Drafting, reviewing, and negotiating a wide range of contracts in support of product development and commercialization (which may include confidentiality agreements, consulting agreements, materials transfer agreements, clinical trial agreements, managed care contracts and various vendor services agreements and master agreements); Developing and implementing training to internal clients, partners and stakeholders on key policies, procedures, practices and requirements for healthcare and related legal compliance, and on current enforcement trends; Advising on transactions to support external collaborations and partnerships, and liaising with partners legal counsel to enable and drive for successful relationship outcomes; and Advising on and supporting international expansion efforts and serving as primary in-house legal contact for ex-US subsidiaries or collaborations. Education & Licenses and Experience 12 or more years of related experience, or the equivalent combination of education and experience. Law degree and licensed to practice law in one or more jurisdictions. 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 life science industries. In-house experience is preferred, and management experience is a plus. Additional Competencies & Skills Ability to work in a fast-paced, dynamic environment with little supervision Ability to prioritize and manage multiple priorities and responsibilities simultaneously and follow-through on issues in a timely manner Demonstrated enterprise and growth mindset Strong cross-functional collaboration skills Ability to establish and maintain good working relationships with personnel and to handle confidential information sensitively and discreetly Strong verbal and written communication skills, including communicating complex legal issues in a digestible manner for internal clients Strong attention to detail Proficient in the use of business productivity software (Word, PowerPoint, Excel, etc.) Travel to the corporate office may be required up to 20% of time worked Arcutis requires all staff in the United States to be vaccinated and boosted from COVID 19 as a condition of employment. In accordance with applicable law, Arcutis will provide reasonable accommodations to staff members who request and qualify for an accommodation(s) on the basis of a medical reason or religious exemption, as long as such accommodation(s) does not pose an undue hardship to Arcutis, its operations, or its staff.

Keywords: Arcutis Biotherapeutics, Inc., Anaheim , Associate General Counsel (Executive Director), Executive , Anaheim, California

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