Senior Counsel

Direct Relief is a medical aid nonprofit, active in all 50 states and more than 80 countries, with a mission to improve the health and lives of people affected by poverty or emergencies – without regard to politics, religion, or ability to pay.

Since its founding in 1948 by refugees of WWII, Direct Relief has grown to become one of the country's most effective humanitarian assistance organizations. Its work earns broad recognition from independent charity rating agencies, including a 100% fundraising efficiency rating from Forbes, a top ranking by Charity Navigator, and a spot in Fast Company’s list of “the world’s most innovative nonprofits.” Direct Relief’s impact throughout the world is the result of its dedicated and compassionate people, each of whom plays a critical role in advancing the organization's mission.

Summary:

To be a key contributor within the Legal & Regulatory Affairs department, while collaborating with departments throughout the organization on wide range of business issues, including regulatory and statutory compliance, commercial contracts, healthcare partnerships, infrastructure initiatives, corporate due diligence and dispute resolution; to provide support to all aspects of the organization’s programs for maintaining compliance with regulations regarding the wholesale distribution of prescription drugs, devices, nutritional products, and food supplements; to implement policies and procedures to ensure the facility, personnel, and organizational operations meet federal, state, and local regulations and pharmaceutical industry best practices; to continually improve and update the Standard Operating Procedures (SOPs) relative to the organization’s compliance with regulatory requirements and industry best practices.

The successful candidate will possess knowledge of laws governing the distribution of pharmaceuticals, including FDA regulation (Food, Drug & Cosmetic Act), supply chain integrity (Drug Supply Chain Security Act), fraud and abuse (Anti-Kickback Statute, False Claims Act), privacy (HIPAA), and anti-corruption (Foreign Corrupt Practices Act).

Key Duties and Responsibilities:

• Support and report to the Vice President of Legal & Regulatory Affairs on all legal and regulatory matters.
• Provide timely regulatory and statutory advice to management and department heads upon request.
• Work collaboratively with all departments to develop strategies and resolutions to unique legal, regulatory, and/or organizational challenges.
• Support the Vice President of Legal & Regulatory Affairs in the oversight and management of legal work performed by Direct Relief’s retained counsel in the United States, Mexico, and Puerto Rico.
• Maintain familiarity with federal and state law governing the distribution of pharmaceuticals, including the Food Drug & Cosmetic Act and Drug Supply Chain Security Act, as well as pharmaceutical industry trends and best practices.
• Maintain working knowledge across all areas of law implicating the broad and diverse operations of Direct Relief, including but not limited to Executive Orders, Export Controls, Patient Privacy, Anti-Kickback, Anti-Terrorism, Foreign Corruption, Labor and Employment, Intellectual Property and Data Privacy.
• Promote best practices to support the enhancement of organizational policies and the development and revision of Standard Operating Procedures (SOPs) consistent with donor requirements (upstream) and partner qualifications (downstream).
• Review, draft, negotiate, and manage a wide variety of contracts, including commercial co-venture agreements, upstream and downstream grant agreements (domestic, international, in-kind, and financial support), private and public medical donation agreements, independent contractor and vendor agreements, purchase and sale contracts and multiparty health infrastructure/development agreements.
• Interface with government oversight and enforcement agencies, including the Office of Inspector General (OIG), Federal Bureau of Investigation (FBI), Bureau of Industry and Security (BIS), Office of Foreign Assets Control (OFAC), California Attorney General, and agencies with jurisdiction over Direct Relief’s operations ex-U.S., such as foreign ministries of health.
• Conduct research and draft memoranda on legal issues relevant to Direct Relief’s operations and objectives.
• Provide litigation/claim support to the Vice President of Legal & Regulatory Affairs and Direct Relief’s outside counsel and insurance carriers.
• Coordinate and assist in all compliance audits and audit responses.
• Proactively identify and mitigate potential exposure to liability in the workplace.
• Collaborate across departments to address compliance issues for investigation and resolution as necessary.
• Support employee training on compliance-related issues, policies, and procedures.
• Support development of International Program Audit and Compliance Support function.
• Support development and oversight of the Compliance Monitoring and Internal Audit Program.
• Support development of Vendor/Supplier Qualification and Audit Program.
• Generate Compliance/Quality reports as directed by the Vice President of Legal & Regulatory Affairs.

Education and Training:

• Experienced practitioner, with eight (8) or more years of relevant law firm and/or corporate in-house law department (preferred) experience. Experience includes working in a regulated industry, such as healthcare, pharmaceutical manufacturing/distribution, insurance or other relevant and regulated fields
• Hold a J.D. or L.L.M with strong academic credentials from an accredited law school and an undergraduate degree from a college or university of recognized standing.
• Admission to the California Bar, and a member of good standing, or eligible to practice as California Registered in-house counsel under California Rules of Court 9.46 required.

Technical Requirements

• Possess knowledge of laws governing the distribution of pharmaceuticals, including FDA regulation (Food, Drug & Cosmetic Act), supply chain integrity (Drug Supply Chain Security Act), fraud and abuse (Anti-Kickback Statute, False Claims Act), privacy (HIPAA), and anti-corruption (Foreign Corrupt Practices Act).
• Possess knowledge of corporate and commercial/transactional law and demonstrated expertise in drafting and negotiating a range of commercial agreements. Strong interpersonal and relationship skills and ability to influence diverse stakeholders, navigate controversial situations and change traditional ways of doing business.
• Superior written, verbal, and interpersonal communication skills with an acute ability to listen attentively and to communicate effectively throughout all levels of the organization.
• Strong analytical and conceptual skills, critical thinking, and problem-solving skills.
• Ability to work effectively with cross-functional teams across all levels of staff and build strong relationships with internal and external stakeholders.
• Ability to produce high-quality work under significant deadline pressures.
• Adaptive to changing priorities and able to juggle multiple assignments.
• Self-directed and able to take initiative.
• Ability to travel up to 10% of the time.
• Detail-oriented with the ability to take initiative and work independently.
• Clear background check and toxicology screening.

We appreciate your interest in employment with Direct Relief. Direct Relief is committed to creating a diverse environment and is proud to be an equal opportunity employer. We welcome all applicants regardless of race, color, religion, creed, national origin, ancestry, sex, gender, age, physical or mental disability, veteran or military status, genetic information, sexual orientation, gender identity, gender expression, marital status, or any other legally recognized protected basis under federal, state, or local law to apply and be part of our growing team.