Brand Counsel

Description : 

Brand Counsel will serve as legal advisor and strategic partner to the Company’s cross-functional brand team, providing day-to-day legal guidance to the sales, marketing, market access, and medical affairs teams in support of both pre-launch preparation and ongoing commercialization activities. The Brand Counsel will serve as a legal reviewer on the promotional review committee and medical review committee, reviewing promotional, non-promotional, and scientific materials for compliance with FDA regulations and other applicable laws, and will lead the drafting and negotiation of contracts with the Company’s customers (including, without limitation, payors, pharmacies, and other trade partners).

Location: Warren, New Jersey - minimum 3 days on site

Salary Range : $250-290k

Key Responsibilities : 

· Serve as legal advisor and strategic partner to the cross-functional brand team in support of the Company’s marketed and pipeline products.

· Counsel internal stakeholders on advertising and promotion laws and regulations, including FDA requirements, the Anti-Kickback Statute, the False Claims Act, and other applicable federal and state laws.

· Serve as legal reviewer on the promotional review committee and medical review committee, reviewing promotional, non-promotional, and scientific materials for compliance with FDA advertising and promotional requirements.

· Advise the sales, marketing, and market access teams on customer contracting, patient services, hub services, and reimbursement support initiatives.

· Draft and negotiation and drafting of contracts with payors, pharmacies, group purchasing organizations (GPOs), and other customers, as well as agreements with advertising, market research, and other commercial vendors.

· Manage outside counsel supporting commercial and promotional legal matters, as needed.

Qualifications : 

· JD from an accredited law school

· Active law license in good standing in New Jersey (or eligibility for in-house/corporate counsel registration)

· Minimum 5 years’ relevant experience in a pharmaceutical or biotech company and/or in a law firm representing pharmaceutical or biotech clients.

· Experience advising commercial (including marketing, sales, and market access) and medical teams in connection with pre-launch and post-launch activities.

· Experience with FDA regulations related to advertising and promotion (AdPromo), and experience serving as the primary legal reviewer on a promotional review committee.

· Experienced drafting and negotiating commercial agreements, including with payors, pharmacies, and other trade customers.

· Experience with healthcare compliance laws, including the Anti-Kickback Statute and the False Claims Act.

· Ability to think critically, proactively identify issues, and offer pragmatic, actionable solutions.

· Manage multiple projects, set priorities, and meet competing deadlines.

· Engage effectively with cross-functional teams across multiple time zones and locations.

· Strong oral, written and presentation skills with the ability to communicate complex compliance matters effectively to diverse audiences.

Behavioral skills :  

• Curiosity: Keep on exploring uncharted territories. Always ask “why?” and more importantly “why not?”,

• Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions,

• Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals,

• Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology.