The Assistant General Counsel directly provides legal advice to the employees of New England Donor Services, Inc. and its subsidiary New England Organ Bank, Inc. (“NEDS”) assuring the appropriate consideration of strategic Legal issues and risk reduction in the achievement of the organization’s mission and goals.  The Assistant General Counsel will provide legal advice and counsel in a variety of areas including general healthcare laws and regulations, laws and regulations governing organ procurement organizations and tissue recovery agencies, contract drafting and negotiation, employment and employee relations, health care compliance and corporate law.  In addition, the Assistant General Counsel will assist the Chief Legal Officer in matters as required.This is a hybrid position with travel to the Waltham office as needed. There is also an on-call requirement  50% of the time. Knowledge of organ and tissue donation processes and terminology. Knowledge of laws, regulations, and policies (federal and state) that apply to organ and tissue donation and transplant strongly preferred. Admitted to the Massachusetts Bar or eligible for admission within six months.FOCUS AREAS/ESSENTIAL JOB FUNCTIONS:Regulatory Compliance:Advise on federal and state healthcare laws and regulations, including the National Organ Transplant Act and implementing regulations, the Uniform Anatomical Gift Act, Human Cells, Tissues, and Cellular and Tissue-Based Products regulations and relevant fraud and abuse laws.Provide advice on compliance with CMS Conditions of Participation and OPTN PoliciesSupport the corporate compliance program and provide legal advice related to compliance matters, including conflicts of interest and data privacy and securityConducts legal research and analysis on relevant laws, regulations, and case law, writing legal memoranda as requestedAssist with investigations and responses to CMS, OPTN or other government inquiries or enforcement actionsMonitor and interpret emerging regulatory changes and advise on operational impact and risk mitigation strategiesAssist in responding to and drafting proposed legislation and regulation impacting NEDSAssists Chief Legal Officer in overseeing the NEDS Compliance Program and Conflict of Interest ProcessOperational Legal SupportDrafts, reviews and negotiates agreements including vendor, services and supplier agreementsResponds to subpoena requests and requests for donor and other records from regulatory agencies, donor families and third partiesAssists in drafting and revising organizational policies and procedures to ensure compliance with applicable laws and regulationsParticipates in on-call rotation to serve as a real-time/on call resource to clinical staff for legal issues, which may arise during donation casesAssists Privacy and Security Officers to maintain policies and procedures related to information privacy and security programManages the organization’s emergency response program. Maintains and updates emergency preparedness program. Conducts risk assessments, plans tabletop exercises, and emergency drills. Coordinates with local and regional officials and partners in emergency planning.Assists Chief Legal Officer and Human Resources staff in addressing employee relations matters.TrainingProvide New Hire Orientation Compliance and Legal issues trainingProvide training to staff on matters related to laws and regulations governing donation and transplant as needed and determined by the Chief Legal Officer and organization leadership.Provide training to external stakeholders on legal issues related to donation and transplantationLitigation and Risk ManagementAssists Chief Legal Officer in managing litigation, including reviewing motions, discovery, pleadings, and communicating with outside counselAssists Chief Legal Officer in organizational risk mitigation efforts including oversight of Conflict of Interest process, adverse event investigation, RCA and CAPA process and collaboration with the Information Technology Department to identify and address programmatic risk related to privacy and security
