Job Title: Senior Commercial Attorney
Job Responsibilities:
The Senior Commercial Attorney is responsible for providing legal expertise and support to the company in areas related to product marketing, promotional activities, commercial operations, and pricing compliance. This role involves close collaboration with various internal departments including commercial, marketing, market access, finance, clinical, and manufacturing to protect the company from legal risks, support business objectives, and ensure adherence to company guidelines.
Key responsibilities include:
- Providing legal advice on all aspects of the company's commercial activities, such as product launches, promotional materials, medical education programs, advisory boards, speaker bureaus, research and foundation grants, sponsorships, charitable contributions, and corporate giving.
- Offering guidance on go-to-market strategies, distribution models, payer coverage, and pricing frameworks.
- Reviewing promotional materials, marketing campaigns, and patient engagement programs for regulatory compliance.
- Advising on interactions with healthcare professionals, patient advocacy groups, and payer organizations, including speaker programs and medical education initiatives.
- Ensuring compliance with laws and industry guidelines on advertising, promotion, and product labeling.
- Serving as the Legal representative on the company's Promotional Review Committee.
- Providing legal advice to field-based teams, including sales, reimbursement, and market access personnel, and advising on sales team trainings and incentive compensation programs.
- Working with the compliance team to ensure adherence to laws such as the False Claims Act, Anti-Kickback Statute, Foreign Corrupt Practices Act, and state/federal transparency laws.
- Supporting medical communications, disease awareness campaigns, and marketing initiatives.
- Providing legal guidance on pricing strategies, contracting, and compliance with government price reporting requirements, including Medicaid and Medicare, 340B Drug Pricing Program, and the Inflation Reduction Act.
- Advising on payer negotiations, value-based agreements, and commercial insurance reimbursement strategies.
- Supporting government price reporting compliance and providing legal risk assessments for pricing and contracting initiatives.
- Advising on state drug price transparency laws and compliance with Medicaid rebate programs.
- Drafting, negotiating, and reviewing pricing, distribution, payer, and reimbursement agreements.
- Managing legal aspects of patient support programs, reimbursement hubs, and pharmacy benefit manager agreements.
- Advising on manufacturer coupon programs, patient assistance programs, co-pay assistance, and hub service compliance.
- Training internal stakeholders on pricing, reimbursement, and commercial compliance issues.
- Monitoring regulatory changes and enforcement trends in pharmaceutical commercialization.
- Collaborating with cross-functional teams on new product development, lifecycle management, and marketing support.
- Developing and implementing policies, procedures, and controls to ensure legal and regulatory compliance.
- Identifying risks and issues proactively and providing alternatives that meet business objectives while reducing risk.
- Ensuring clear communication with internal stakeholders and outside parties regarding contract status or issues.
- Handling miscellaneous legal tasks or special assignments as needed.
Education and Experience Information:
- Juris Doctorate from an accredited law school, and admission to a US state bar in good standing.
- A minimum of 8+ years of experience in a major law firm and/or in-house.
- Experience in supporting product launches in the life sciences industry is required, with a preference for pharmaceutical sector experience.
- Strong knowledge of relevant federal and state laws, regulations, rules, and guidance, as well as industry codes impacting pharmaceutical manufacturers, focusing on drug labeling, advertising, fraud and abuse, product liability, and clinical trials.
- Precise drafting and strong legal analysis skills.
- Excellent written and oral communication skills; professional manner and ability to work effectively with all levels of management and personnel.
- A keen understanding of business and practical problem-solving skills, presenting creative solutions and alternatives for management.
- Ability to handle competing priorities in a fast-paced environment and exercise sound commercial and legal judgment.
- Self-starter capable of working independently and collaboratively in a team environment.
Salary Information:
The pay range for the Senior Commercial Attorney role is $230,000-$260,000 annually. Actual compensation packages are determined based on factors unique to each candidate, including skill set, depth of experience, certifications, and specific work location. The total compensation package may also include bonuses, stock options, benefits, and other variable compensation elements.
