Associate Director, Legal, Corporate Counsel, Product and Commercial (Biotechnology)

Location: San Rafael and Novato, California, United States

Company

hirify.global is a biotechnology company developing therapies for rare diseases and genetically defined conditions.

What you will do

• Advise internal stakeholders on advertising, promotion, external communications, sales, marketing, market access, patient advocacy, and medical affairs activities.
• Serve as legal reviewer for MLR committees supporting assigned products and disease states.
• Draft, review, and negotiate commercial agreements for the Commercial organization.
• Provide guidance and training on healthcare compliance, FDA and OIG requirements, industry codes, anti-kickback rules, false claims, and product liability.
• Support compliance risk assessments, investigations, corrective action plans, and collaboration with Global Compliance & Ethics.
• Prepare executive briefings on enforcement trends, OIG and FDA developments, CIA trends, and OPDP warning and untitled letters.

Requirements

• JD degree and active bar license required.
• 3–7 years of experience in a law firm, pharmaceutical legal or healthcare compliance function, regulatory agency, or major law firm.
• Experience supporting pharmaceutical or biotechnology pipeline and marketed products, including advertising and promotion and MLR review.
• Experience drafting, reviewing, and negotiating commercial agreements.
• Knowledge of OIG Guidance, Federal Sentencing Guidelines, healthcare compliance programs, Anti-Kickback Statute, False Claims Act, and clinical trial regulations.
• Strong written, oral, presentation, problem-solving, risk analysis, project management, collaboration, and business judgment skills.

Culture & Benefits

• Work with cross-functional teams supporting therapies for patients with rare diseases.
• Collaborate with stakeholders across Commercial, Marketing, Sales, Market Access, Medical Affairs, Patient Advocacy, Corporate Communications, and Global Compliance & Ethics.
• Operate in a complex pharmaceutical and biotechnology regulatory environment.