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    Director, Compliance - San Diego, United States - Arrowhead Pharmaceuticals, Inc.

    Arrowhead Pharmaceuticals, Inc.
    Arrowhead Pharmaceuticals, Inc. San Diego, United States

    3 weeks ago

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    Description
    Arrowhead Pharmaceuticals, Inc

    (Nasdaq:

    ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them.

    Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes.

    RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein.

    Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.


    Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease.

    The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics.

    Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

    Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI and San Diego, CA. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

    The Position


    The purpose of this position within the Quality and Compliance department is to provide leadership and oversight of healthcare compliance program and policies worldwide, with emphasis on the US healthcare compliance.

    A key function of the position will involve continued development, maintenance, monitoring, and execution of the compliance program and corporate policies at Arrowhead.


    This position will report to the Vice President Quality and Compliance and work closely with members of the Legal, Medical, Regulatory, Quality, and Commercial teams to promote awareness and understanding of positive ethical principles and ensure continuous suitability and alignment of compliance program framework and controls with relevant laws and company's goals.

    Responsibilities

    Serve as an internal subject matter expert in the field of healthcare compliance and advise internal stakeholders and management on matters related to healthcare compliance
    Monitor legislative landscapes, compliance trends, and recent enforcement activities by relevant government authorities to provide updates to management
    Implement and oversee company-wide healthcare compliance program, policies, and controls
    Develop and evolve relevant and robust policies and other guidance documents to ensure compliance with applicable laws and regulations, and industry standards
    Proactively drive culture of compliance by drafting and disseminating written materials and training that are aimed at increasing stakeholders' awareness and understating of relevant regulatory requirements and industry standards
    Conduct compliance risk assessments and coordinate implementation of necessary mitigation actions, aligned with evolving regulatory requirements, industry standards, and business initiatives and strategies

    With support from Legal department, lead internal investigations related to the compliance program and if required, implementation of applicable corrective and preventative measures and reporting to relevant government agencies.

    Participate in the due diligence and/or qualification of/by third parties
    Prepare and present periodic reports and status of compliance to management, including the measures and activities to ensure compliance
    Other duties as assigned


    Requirements:
    BS or BA degree with at least 10 years of relevant experience

    Working knowledge of of Federal Anti-Kickback Law, False Claims Act, US FDA and EMA Laws and Regulations, and relevant Federal and State Consumer Protection Laws, PhRMA Code, ACCME, EFPIA, and FCPA.

    Competent knowledge of and ability to use Microsoft Office suite
    Ability to follow company procedures, work instructions, and policies
    Ability to process, synthesize and summarize complex issues
    Excellent judgment, and analytical, problem-solving skills
    Work in a safe manner; properly handle materials and chemicals
    Excellent attention to detail and organizational skills
    Ability to multi-task and prioritize work tasks with minimal supervision
    Excellent interpersonal, verbal, and written communication skills


    Preferred:
    JD or Master's degree in relevant area
    Prior experience with use of an electronic document management system in a regulated environment
    Relevant Compliance and ethics Professional certification

    California pay range

    $180,000—$225,000 USD

    Arrowhead provides competitive salaries and an excellent benefit package.

    All applicants must have authorization to work in the US for a company.

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