Assistant General Counsel

New England Donor Services•Waltham, MA

1d•Hybrid

About The Position

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”) to ensure appropriate consideration of strategic legal issues and risk reduction in achieving the organization’s mission and goals. This role involves providing legal advice and counsel in various areas including general healthcare laws and regulations, laws governing organ procurement organizations and tissue recovery agencies, contract drafting and negotiation, employment and employee relations, health care compliance, and corporate law. The Assistant General Counsel will also assist the Chief Legal Officer as required. This is a hybrid position requiring travel to the Waltham office as needed and includes an on-call requirement 50% of the time.

Requirements

J.D. from an accredited institution
4-6 years of practice as a health care attorney representing hospitals and healthcare providers
Admitted to the Massachusetts Bar or eligible for admission within six months
Ability to research, analyze and interpret regulatory information and determine its potential impact to the organization
Experience in drafting and negotiating agreements and have a clear understanding of the lawyer's role as a legal and business advisor
Demonstrated ability to lead, organize, and manage multiple projects, adapt to changing priorities, and utilize time-management skills to meet deadlines
Ability to identify and appropriately balance risks and alternatives
Ability to analyze highly complex situations with multiple variables and make sound recommendations
Makes sound decisions under pressure and is willing to make difficult and unpopular decisions when necessary
Is a self-starter
Able to successfully prioritize when faced with demands, requests and deadlines
Knowledge of employment law and human resources management
Ability to handle highly confidential information in a professional manner
Ability to prioritize and manage diverse business priorities to meet deadlines in a fast-paced environment
Strong written and verbal communication skills
Strong interpersonal skills and ability to critically think, problem solve, and work productively both independently and as a team participant
Proficiency Microsoft 365 suite

Nice To Haves

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
Preference for experience as in-house counsel

Responsibilities

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 Policies.
Support the corporate compliance program and provide legal advice related to compliance matters, including conflicts of interest and data privacy and security.
Conducts legal research and analysis on relevant laws, regulations, and case law, writing legal memoranda as requested.
Assist with investigations and responses to CMS, OPTN or other government inquiries or enforcement actions.
Monitor and interpret emerging regulatory changes and advise on operational impact and risk mitigation strategies.
Assist in responding to and drafting proposed legislation and regulation impacting NEDS.
Assists Chief Legal Officer in overseeing the NEDS Compliance Program and Conflict of Interest Process.
Drafts, reviews and negotiates agreements including vendor, services and supplier agreements.
Responds to subpoena requests and requests for donor and other records from regulatory agencies, donor families and third parties.
Assists in drafting and revising organizational policies and procedures to ensure compliance with applicable laws and regulations.
Participates in on-call rotation to serve as a real-time/on call resource to clinical staff for legal issues, which may arise during donation cases.
Assists Privacy and Security Officers to maintain policies and procedures related to information privacy and security program.
Manages 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.
Provide New Hire Orientation Compliance and Legal issues training.
Provide 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 transplantation.
Assists Chief Legal Officer in managing litigation, including reviewing motions, discovery, pleadings, and communicating with outside counsel.
Assists 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.