We are partnered with a rapidly growing biotech company dedicated to developing novel therapeutics with a strong focus on the orphan disease space. This SF-based company offers a unique opportunity to join a biotech company with a noble mission, working alongside a passionate team with a strong focus on the patient population it aims to treat.
Our client is looking to add a Head of Compliance with extensive past compliance experience in the Pharma/Biotech/Healthcare space. This role will report to the General Counsel and oversee the company's compliance functions. The ideal candidate will have experience supporting commercial, R&D, clinical, medical affairs, and regulatory functions, as well as expertise in sales and marketing compliance, privacy compliance, and data governance.
Key Responsibilities:
- Implement and maintain policies for HCP, sales and marketing compliance, privacy compliance, and data governance.
- Provide guidance on interactions with patients and HCPs, including fair market value and advisory board participation.
- Monitor regulatory landscapes, develop internal training, and ensure compliance with GDPR and HIPAA.
- Serve on various committees, including promotional review, medical review, and compliance committees.
Qualifications:
- 10+ years of compliance experience within biotech, pharmaceutical, or healthcare companies; experience with product launches is highly desirable.
- J.D. from an accredited law school and an active state bar membership (preferably California).
- Familiarity with healthcare corporate compliance, sales and marketing compliance, privacy compliance, data governance, and U.S. Sunshine Act/state law reporting.
- Strong knowledge of laws, regulations, industry standards, and guidelines for interactions with healthcare professionals (HCPs).
- Ability to provide guidance on U.S. advertising and promotion laws.
- Willing to be on-site 2-3 days/week
