Director, Legal

Overview

This clinical-stage biopharmaceutical organization is seeking a Director, Legal to serve as the lead legal reviewer for promotional and medical materials. The role represents Legal in the Medical, Legal, and Regulatory (MLR) review process, sits on the Promotional Review Committee (PRC) and Medical Review Committee (MRC), and helps design standards and procedures to review materials quickly—supporting planned launch and commercialization.

This is a hands-on attorney role well-suited for someone who can deliver clear, practical legal guidance in a fast-moving remote environment and values autonomy.

Reporting to the VP, Commercial Legal, the position provides practical legal guidance across advertising and promotion, medical affairs activities, commercial operations, market access initiatives, and product launch planning.

Responsibilities

• Serve as Legal representative on the PRC and MRC, reviewing HCP-facing, patient-facing, medical, and corporate materials for compliance with:
  • the Federal Food, Drug, and Cosmetic Act (FDCA)
  • FDA advertising and promotion regulations
  • FTC requirements
  • other relevant industry codes
• Provide legal guidance across pre-launch and launch activities, balancing legal risk with business objectives
• Review patient materials, including patient education, disease awareness content, website and digital content, and patient support program communications, to ensure regulatory compliance
• Evaluate claims for substantiation, fair balance, and net impression, including comparative, subgroup, and pharmacokinetic claims; provide clear direction to reviewers and authors
• Advise on pre-approval communications, including scientific exchange, disease awareness, medical education, congress activity, and boundaries between investor/corporate messaging and promotion of an investigational product
• Review non-promotional and medical affairs materials, including responses to unsolicited requests, payor and formulary communications, and digital and social media content
• Provide guidance on navigating the regulatory landscape in business activities such as disease education, HCP engagement, and patient-facing materials
• Support corporate legal matters and business development initiatives as needed

Requirements

• JD from an accredited law school and active membership in at least one U.S. state bar
• 6+ years of legal experience within the pharmaceutical, biotechnology, or life sciences industry
• Strong knowledge of FDA advertising and promotion regulations and commercial legal requirements
• Knowledge of product launch planning and commercialization activities
• Experience reviewing HCP and patient materials and advising on patient support programs, including hub services, co-pay assistance, and nurse or educator programs
• Experience supporting a product launch, ideally with a pre-commercial or newly commercial biotechnology company

Preferred Qualifications

• Experience with patient support programs and related materials

Compensation & Benefits

• Eligible for standard benefits including medical, dental, vision, time off, and 401K
• Participation in incentive plans is contingent on achievement of personal and company performance
• Actual compensation may vary from the posted hiring range based on geographic location, work experience, education, and/or skill level
• US Salary Range: $185,000 - $232,000

Location

• Fully remote
• Travel required: up to 10%; frequently travel is outside the local area and includes overnight stays

Additional Information

• This position is eligible for standard company benefits and is marked as remote ("#LI-Remote").