Senior Director, Deputy General Counsel - WHQ

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POSITION SUMMARY:

This Deputy General Counsel position is responsible for a broad array of legal and regulatory issues faced by NMDP, generally supporting the advice and counsel work of NMDP’s Office of General Counsel function, management of organizational risks, and assisting in the management of NMDP litigation and claims.  This position participates in the creation, development and implementation of NMDP policies and procedures with respect to its legal and regulatory obligations.  

Maintains a wide scope of knowledge of pertinent laws, regulations, rulings, interpretations and court decisions as they affect NMDP, and a knowledge of risk management concepts and methods.  Performs other related duties incidental to the work described herein and as assigned.

This position also provides advice and support to NMDP’s Contracts and Procurement function, including contract compliance with internal policies and procedures and government regulations, project management and the establishment and management of strategic partnerships.  Responsible for the program management and coordination of business functions for NMDP’s research programs, including related activities within contracts, procurement, legal and finance.  

The position will oversee attorneys, paralegals, and outside consultants/counsel and will provide direction to the teams to assist them in providing efficient and effective services. This position is onsite at our World Headquarters.  #LI-Onsite

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ACCOUNTABILITIES:

Legal Research, Analysis and Support:

• In consultation with the General Counsel, provides legal counsel and guidance to officers and upper management on legal matters relevant to NMDP.
• Performs substantial and complex legal research and analysis and provides advice and counsel regarding all legal matters relevant to NMDP, including but not limited to: federal and state laws affecting healthcare compliance and privacy regulations; human subjects and research related regulations; marketing and communications regulations; and domestic and international cell and gene therapy regulations. 
• Assists in the anticipation and identification of legal issues of concern to NMDP and assists in the development of legal strategies and solutions, often in situations of financial, political and/or public relations risk or significance, and with limited time for assessing alternatives.
• Assists in the coordination of activities and actions involving outside counsel retained to represent NMDP.
• Primary responsibility over litigation and claims management.
• Drafts and reviews legal documents, including but not limited to contract drafting and review of contracts.  In particular, provide legal support to the Contracts & Procurement department that includes analysis and review of contract terms that have a legal and/or regulatory/compliance concern.
• Assists in the review, negotiation and management of, and compliance with, contracts with governmental entities.

Policy Development, Preparation, and Implementation:

• Assists with review, analysis, development, and implementation of NMDP policies and procedures having legal compliance components.
• Assists departments throughout the company with developing and modifying practices and procedures to conform to legal and regulatory requirements.
• Assembles and organizes information for policy and procedure documents.

Information Security and Data Privacy:  

• In partnership with the Vice President of Information Security, Infrastructure, and Architecture, prepares and provides guidance and assistance in relation to implementation and maintenance of information security and data privacy risk management and organization data privacy policies, procedures, and practices. Creates and executes strategic plans with regard to the future of NMDP’s data privacy policies, procedures, and practices.
• Maintains current knowledge of applicable federal and state data privacy laws, requirements, and accreditation standards, and monitors advancements in data privacy developments and technologies to ensure organizational adaptation and compliance.
• Ensures compliance with data privacy policies, procedures, and practices and consistent application of responses to failures to comply with data privacy requirements, for organizational staff, network centers, and others subject to relevant NMDP policies, in cooperation with Human Resources, administration, legal counsel, and other relevant staff, as may be applicable.
• Manages data privacy breach program to support responses to data privacy incidents and breaches.
• Provides direction, advice and counsel, and support to NMDP departments charged with the receipt, handling, and maintenance of confidential information.
• Develops, manages and advises on data retention policies and procedures.

Risk Management:

• Works closely with senior management to identify and mitigate legal risks related to business operations and provides advice on risk management strategies.
• Engages in ongoing legal and business activities related to NMDP’s insurance portfolio, including analysis of insurance coverage requirements and issues, regular communications with brokers and/or insurers, and administrative tasks related to insurance documentation.

Other Areas:

• Provides legal support for clinical research, trials and studies, and ensures compliance with applicable regulations, including advising on research-related agreements, informed consent forms, patient privacy issues, and IRB matters.
• Leads or assists with internal investigations.
• Responsible for safeguarding NMDP’s intellectual property assets by using appropriate patent, copyright, trademarks, trade secret, and technical data/software agreements and provisions.  Manages activities with outside counsel to review and conduct relevant intellectual property filings.
• Provides support and legal research and advice to Regulatory and Quality teams for both core business and cell and gene therapies activities.
• Develops and delivers training programs for employees on legal and compliance issues, promotes awareness of legal issues and keeps the organization informed about changes in laws and regulations that may affect business operations.
• Assists in the selection, training, development, and supervision of departmental personnel.
• Provides support to the General Counsel on corporate governance, strategic planning, and high-level legal matters; assists with department budgets; and leads or participates in special projects and initiatives as needed.