Biopharmaceutical Attorney (Part-Time)

Core Responsibilities

• Review of clinical trial site confidentiality and non-disclosure agreements, clinical trial agreements and country-specific informed consent form templates
• Review and negotiate clinical trial site confidentiality and non-disclosure agreements, clinical trial agreements and informed consent forms across various global regions for Phase 3 clinical trials
• Collaborate with internal clinical operations, clinical development and regulatory teams and our external clinical research organization in the review of clinical trial related documents
• Review and negotiate confidentiality and non-disclosure agreements, master services agreements, consulting agreements and statements of work
• Initial and ongoing development of clause playbooks and negotiation parameters for clinical trial related contracts and vendor related contracts

Qualifications/Skills

• Minimum of 5-8 years of legal experience with public biotechnology or pharmaceutical companies
• Strong knowledge of laws and regulations relevant to the industry, including FDA law and regulations, GCP as adopted by the FDA and ICH, US Anti-Kickback Statute, and global Anti-Fraud statutes
• Deep understanding of applicable data privacy and data governance regulations both in the US and internationally
• Strong experience negotiating with universities and academic medical centers in the US and internationally

Benefits/Perks

• Fully remote
• No travel required
• Flexible hours