Overview
A biopharmaceutical organization focused on rare diseases is seeking a Senior Legal Counsel to support its upcoming U.S. product launch and ongoing commercial operations. This role will provide legal guidance across commercial, regulatory, and operational activities, ensuring compliance with U.S. healthcare laws and supporting the company’s growth in the U.S. and globally.
Responsibilities
- Provide legal support for all U.S. commercial, regulatory, and operational activities throughout the product lifecycle, including pre-launch, launch, and post-launch phases.
- Draft, review, and negotiate agreements with commercial partners and service providers.
- Advise on risk assessment and mitigation, delivering clear and actionable guidance aligned with business objectives.
- Ensure compliance with U.S. healthcare regulations, including HIPAA, anti-kickback statutes, and commercial practices.
- Serve as a legal resource and sounding board for cross-functional teams such as Commercial, Legal, Market Access, and Medical Affairs.
- Navigate ambiguity with a solution-oriented and agile approach.
- Contribute to cross-border legal projects and help align U.S. and EU compliance frameworks as the organization expands globally.
- Maintain a proactive and collaborative approach in a fast-paced, resource-conscious environment.
Requirements
- Juris Doctor (JD) or equivalent legal qualification with admission to practice law in the U.S.
- Minimum of 7 years of experience in biotech or pharmaceutical law, with proven support for U.S. commercial product launches.
- In-depth knowledge of U.S. healthcare and commercial law, including regulatory and compliance obligations relevant to rare diseases.
- Expertise in privacy law and healthcare compliance, including HIPAA, Sunshine Act, and Anti-Kickback Statute.
- Strong negotiation skills with sound judgment balancing risk and business needs.
- Excellent communication skills, clear and commercially focused.
- Highly organized, self-directed, and effective in a lean, entrepreneurial environment.
- Experience with international legal matters is preferred.
Location
This is a remote position; however, candidates based in the Greater Boston or Massachusetts area are preferred for in-office collaboration.
Compensation & Benefits
Details regarding compensation and benefits will be provided during the recruitment process.