This position is part of an enterprise-wide law department responsible for providing assistance to the General Counsel and Deputy General Counsel in providing legal advice to the organization and its geographical divisions in all areas of legal affairs managed by the Office of the General Counsel, with a particular focus on healthcare law, regulatory compliance, commercial transactions and corporate matters within highly regulated industries. Experience in pre-clinical and clinical research agreements a plus.

• Assist with the management of enterprise-wide legal matters, with a focus on healthcare law, regulatory compliance, research contracting, intellectual property and corporate transactions and legal issues affecting the organization’s operations and mission.
• Provide legal counsel on FDA and other applicable federal and state healthcare laws and regulations governing the organization’s operations, including requirements related to blood components, biologics, donor eligibility, product quality, labeling, recordkeeping, regulatory reporting, and applicable Centers for Medicare & Medicaid Services (CMS) requirements.
• Advise on the development, implementation, and oversight of healthcare regulatory compliance programs, including policies, procedures, training, monitoring, audits, and corrective action plans.
• Advise on healthcare privacy and data protection requirements, including HIPAA and applicable state privacy laws, and the appropriate use, disclosure, and safeguarding of protected health information and other sensitive data.
• Support the development, review, and negotiation of a broad range of agreements with hospitals, health systems, blood collection partners, laboratories, suppliers, research institutions, and other organizations.
• Lead contracting for research-related matters, including material transfer agreements, collaborations, and sponsorships, and advise on research compliance, human subjects protection, informed consent, and applicable FDA requirements for clinical trials.
• Work with the Deputy General Counsel to prepare and file the organization’s annual federal Open Payments (Physician Payments Sunshine Act) report and any applicable state transparency reports.
• Monitor and advise on emerging healthcare laws, regulations, and industry developments affecting the organization’s operations, strategic initiatives, and mission.
• Advise on legal and regulatory matters related to the organization’s not-for-profit status, including charitable purpose, corporate governance, conflicts of interest, and applicable tax-exempt organization requirements.
• Advise on research related matters, including in areas of research compliance and human subjects’ protection.
• Manage outside counsel in a cost-effective manner.
• Interact with senior executives and Board members of the organization with respect to general corporate policy and governance matters. 
• Assist the Risk Management team with identifying legal risks related to blood center operations, incident response and investigations, risk mitigation strategies and development of policies that align with regulatory and legal requirements. 
• Work as an individual or on a team for assigned special projects.
• Attend professional development programs as required.
• Any related duties as assigned.

Education:

• Juris Doctor and current and valid admission to New York Bar.

Experience:

• Minimum four to six years’ experience in a law firm, non-profit or in-house corporate entity with demonstrated experience in healthcare law, FDA regulations, and healthcare regulatory compliance.
  
• Experience advising on applicable federal and state healthcare laws and regulations, commercial transactions, contract drafting and negotiation, and corporate matters is required.

Required Licenses / Certification:

• License to practice law in New York.

Knowledge:

• Expert knowledge of legal practices, policies and procedures as they relate to corporate and commercial matters in the non-profit and pharmaceutical/healthcare industry.

Skills:

• Cultural competency and the ability to communicate effectively in a culturally sensitive manner with both individuals and groups from diverse backgrounds.
• High level of interpersonal skills to handle a variety of complex issues and situations. Position requires demonstrated poise, tact and diplomacy in dealing with a variety of staff up to and including executive leadership.
• Strong attention to detail in all research and work processes.

Abilities:

• Ability to travel, up to 10% travel.
• Ability to conduct research on various topics.
• Ability to work independently with minimal supervision.
• Ability to communicate clearly and with authority, both in writing and verbally, to others in one-on-one or small group settings.
• Ability to interact with individuals at all levels of the organization and customers in a helpful, courteous and friendly manner while demonstrating sensitivity to and respect for diverse populations.
• Ability to work in a strong team environment.
• Ability to plan and organize job tasks or resources in an efficient manner.
• Ability to be responsive and available to management in order to address issues and concerns as they arise.
• Ability to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands.
• Ability to use logic and reasoning to identify and analyze the strengths and weaknesses of alternative solutions, conclusions or approaches to problems within established policies and procedures.
• Ability to identify complex problems in a timely manner, decipher information to develop and evaluate options and implement solutions.
• Ability to handle and work with sensitive and confidential information and maintain confidentiality.
  

Any combination of education, training, and experience equivalent to the requirements above that has supplied the necessary knowledge, skills, and experience to perform the essential functions of the job.

For applicants who will perform this position in New York City or Westchester County, the proposed annual salary is $170,000.00p/yr. to $180,000.00p/yr. For applicants who will perform this position outside of New York City or Westchester County, salary will reflect local market rates and be commensurate with the applicant’s skills, job-related knowledge, and experience.

Founded in 1964, New York Blood Center (NYBC) has served the tri-state area for more than 60 years, delivering 500,000 lifesaving blood products annually to 150+ hospitals, EMS and healthcare partners. NYBC is part of New York Blood Center Enterprises (NYBCe), which spans 17+ states and delivers one million blood products to 400+ U.S. hospitals annually. NYBCe additionally delivers cellular therapies, specialty pharmacy, and medical services to 200+ research, academic and biopharmaceutical organizations. NYBCe’s Lindsley F. Kimball Research Institute is a leader in hematology and transfusion medicine research, dedicated to the study, prevention, treatment and cure of bloodborne and blood-related diseases. NYBC serves as a vital community lifeline dedicated to helping patients and advancing global public health. To learn more, visit nybc.org. Connect with us on Facebook, X, Instagram, and LinkedIn.

NYBCe is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disabled status, or genetic information.