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ProfileDirector Of Compliance And Commercial Counsel The candidate will be primarily responsible for developing and implementing an integrated compliance plan for potential future commercialization efforts. Will also maintain and enhance compliance program and advise on firm’s potential launch of its first commercial product. Providing direct oversight for complex elements of firm’s compliance program across the organization. Providing expertise on compliance for firm’s potential future commercial programs, identifying and managing complex legal and regulatory issues, analyzing alternatives and proposing solutions. Developing and administering compliance policies and procedures; developing and implementing a monitoring plan, including identifying compliance risk areas and communicating such risk areas to management along with action plans to address risk; and providing oversight and assistance with education and training. Conducting and/or facilitating investigations of suspected non-compliance, making recommendations regarding corrective action, and ensuring completion of any corrective action. Overseeing federal and state Sunshine reporting and related healthcare compliance requirements. Staying current on compliance trends, and providing practical business solutions that maintain the Company’s compliance within an evolving legal landscape. Analyzing advertising and promotional materials, non-promotional disease awareness materials, patient services and patient assistance activities and communications, training materials, speaker program materials, medical education activities, grant requests, and advisory board proposals for the U.S. Market. Drafting and negotiating a range of contracts including non-disclosure, speaker, grant, vendor, consulting, master services agreements, ad board and clinical trial agreements. Leading cross-functional teams on complex compliance issues. Providing guidance and direction to Acceleron management, employees and future sales force as needed. Must have JD degree. Should have 5+ years of experience as a compliance attorney in a commercial biotech/pharma organization. Must be Licensed to practice law in Massachusetts. Should have strong understanding of compliance processes and activities common to the biotech/pharmaceutical industry. Experience building a compliance department within a small to mid-sized organization preferred. Must have experience reviewing advertising and promotional materials for pharmaceutical products, non-promotional disease awareness materials, and patient services/assistance for compliance with legal and regulatory requirements. Should have experience in drafting commercial contracts, advising on commercial and medical activities, regulatory matters, and compliance issues. Must have working knowledge of U.S. healthcare compliance and enforcement environment, False Claims Act, Anti-kickback Statute, anti-bribery considerations, and FDA rules and regulations. Should have experience in conducting investigations and managing the investigations process, including the management and tracking of the investigation lifecycle and the close-out process. Must have experience in the development, initiation, maintenance, and revision of policies and procedures for the general operation of a Compliance Program and its related activities to prevent illegal, unethical, or improper conduct.
24 Emily Street
Cambridge, MA 02139