Corporate Counsel

Direct Relief•Santa Barbara, CA

About The Position

The Corporate Counsel will be a key contributor within the Legal & Regulatory Affairs department, with a focus on commercial agreements and regulatory and statutory compliance. The position will advise on a wide range of business issues, including contract drafting and negotiation, legal requirements applicable to nonprofits, employment matters, and dispute resolution. It will also support the organization’s compliance with regulations regarding the wholesale distribution of prescription drugs, devices, nutritional products, and food supplements, as well as compliance with donor requirements and pharmaceutical industry best practices. The successful candidate will have meaningful experience in contract drafting, review and negotiation, and will be comfortable providing actionable advice on legal risks to business leaders.

Requirements

3 to 5 years of relevant legal experience in a law firm, government, and/or in-house position.
J.D. or L.L.M. from an accredited law school.
Admitted member in good standing of the California Bar, and/or eligible to practice as California Registered in-house counsel under California Rules of Court 9.46.
Experience drafting, reviewing, and negotiating commercial agreements.
Strong written, verbal, and interpersonal communication skills; ability to influence diverse stakeholders; comfortable navigating conflict.
Strong analytical, critical thinking, and problem-solving skills.
Adaptive to changing priorities and able to juggle multiple assignments with deadlines.
Clear background check and toxicology screening.

Nice To Haves

Experience advising the pharmaceutical industry and knowledge of the laws governing the domestic and/or international distribution of pharmaceuticals, including FDA regulation (Food, Drug & Cosmetic Act), supply chain integrity (DSCSA/FMD), fraud and abuse (Anti-Kickback Statute), privacy (HIPAA/GDPR), anti-corruption (FCPA).
Experience advising on nonprofit compliance issues.
Experience interfacing with government oversight and enforcement agencies such as the Bureau of Industry and Security (BIS), Office of Foreign Assets Control (OFAC), Drug Enforcement Agency (DEA), HHS Office of Inspector General (OIG), Federal Bureau of Investigation (FBI), state Boards of Pharmacy, California Attorney General, and/or foreign ministries of health.
Experience advising on US and/or EU export controls.

Responsibilities

Draft, review, and negotiate a wide range of contracts, including upstream and downstream grant agreements (domestic and international), private and public medical donation agreements (domestic and international), vendor and supplier agreements, commercial co-venture agreements, distribution and logistics agreements, employment-related agreements, service agreements, and nondisclosure agreements.
Develop and maintain contract repository, templates, and playbooks; support continuous improvement of contract lifecycle management.
Assist in developing, implementing, and updating compliance policies and standard operating procedures (including, e.g., the employee handbook and policies relating to data privacy, FDA regulations, supply chain integrity, fraud and abuse, and anti-corruption).
Conduct research and draft memoranda on legal issues relevant to Direct Relief’s operations and objectives.
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.
Proactively identify and mitigate potential exposure to liability in the workplace.
Support employee training on compliance-related issues, policies, and procedures.
Maintain familiarity with federal and California law relating to contracts, nonprofit status, and employment matters.
Maintain familiarity with federal and state law governing the domestic and international distribution of pharmaceuticals, including the Food Drug & Cosmetic Act, the Drug Supply Chain Security Act, BIS and OFAC regulations, and pharmaceutical industry trends and best practices.
Support the Legal and Regulatory Affairs department in the review and quality-control of legal work performed by Direct Relief’s retained counsel in the United States, Germany, and Mexico.
Support and report to the Senior Counsel and the Vice President of Legal and Regulatory Affairs on other duties as assigned.