Job Details

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 an expanding organization and work alongside a passionate team with a noble mission.

Our client is looking to add on a Head of Compliance with extensive past experience in the Pharma / Biotech 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:

1. Implement and maintain policies for HCP, sales and marketing compliance, privacy compliance, and data governance.
2. Support sales and commercial marketing teams, ensuring they maintain compliance with industry standards.
3. Monitor regulatory landscapes, develop internal training, and ensure compliance with GDPR and HIPAA.
4. Serve on various committees, including promotional review, medical review, and compliance committees.

Qualifications:

1. 10+ years of compliance experience within biotech, pharmaceutical, or healthcare companies; experience with product launches is highly desirable.
2. Familiarity with sales and marketing compliance, privacy compliance, data governance, AKS, HIPAA, PhRMA Code, and U.S. Sunshine Act / state law reporting.
3. J.D. from an accredited law school and an active state bar membership (preferably California).
4. Strong knowledge of laws, regulations, industry standards, and guidelines for interactions with healthcare professionals (HCPs).
5. Ability to provide guidance on U.S. advertising and promotion laws.