Senior Counsel, Commercial and Compliance

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the main legal advisor for the Commercial and Medical Affairs teams.

• Offer strategic advice throughout pre-launch and launch phases, balancing legal risks with business goals.

• Assist in commercialization preparedness, which includes promotional strategies, market access, patient services, and distribution models.

• Draft, review, and negotiate various commercial agreements (such as vendor contracts, patient support programs, speaker agreements, distribution agreements, and market access contracts).

• Oversee the legal review of promotional and medical materials through MLR/PRC processes.

• Counsel on interactions with healthcare professionals (HCPs), patients, payors, specialty pharmacies, and governmental bodies.

• Support activities in commercial and medical affairs, including speaker programs, advisory boards, sponsorships, grants, medical information inquiries, and scientific exchanges.

• Provide guidance on effectively navigating the regulatory landscape in business activities such as disease education, HCP engagement, advisory boards, and patient-facing materials.

• Lead the development and implementation of a scalable healthcare compliance program that aligns with relevant laws, regulations, and industry standards to ensure commercialization success.

• Create policies, procedures, training, and monitoring frameworks.

• Establish transparency and aggregate spending reporting protocols.

• Proactively identify legal and compliance risks and formulate practical mitigation strategies.

• Keep track of changing healthcare laws, regulations, and industry trends.

• Provide clear, business-focused guidance to senior leadership.

• Assist with corporate legal matters and business development initiatives as necessary.

• Effectively manage external legal counsel.

• Contribute to the development of a high-impact, collaborative legal team.

⛳️ Requirements

• Juris Doctor (J.D.) from an accredited law institution; active bar membership in at least one U.S. jurisdiction.

• 8–12+ years of legal experience in biotech or pharmaceutical sectors (in-house experience preferred).

• Demonstrated experience in supporting commercial development and product launches.

• In-depth knowledge of healthcare and compliance laws and regulations (including FDA, OIG, PhRMA Code, Anti-Kickback Statute, False Claims Act, Sunshine Act, etc.).

• Strong background in MLR/PRC review, promotional regulations, and compliance program development.

• Experience in drafting and negotiating intricate commercial agreements.

• Ability to thrive in a fast-paced, dynamic environment with a high level of accountability.

🏝️ Benefits

• Medical insurance

• Dental insurance

• Vision insurance

• Paid time off

• 401K plan