Partner, FDA Commercialization/Regulatory

Summary

Join Outside GC, a leading provider of on-demand general counsel services, as a Partner specializing in FDA Commercialization/Regulatory. This fully remote position offers flexibility in work arrangements. You will leverage your extensive experience (10+ years in corporate legal practice, including in-house counsel roles and 3+ years of law firm training) to advise drug and medical device manufacturers on FDA regulations and compliance. Success in advising on policy developments, compliance programs, and FDA approval pathways is crucial. You must hold a J.D. from a nationally accredited law school and possess state bar membership. Outside GC values diversity, equity, and inclusion.

Requirements

• At least 10+ years of corporate legal practice, including experience as an in-house attorney, serving as a General Counsel and/or in another senior in-house legal role
• 3+ years of law firm training
• J.D. from a nationally accredited law school
• State bar membership in state where reside/practice
• In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire

Responsibilities

• Advise drug manufacturers on policy developments and enforcement trends in advertising and promotion
• Counsel medical device and technology firms on FDA digital health policies and regulation of mobile medical applications
• Evaluate the effectiveness of FDA and healthcare compliance programs
• Update policies related to communication of scientific and medical information
• Assist in obtaining priority review vouchers and modifying post-marketing studies
• Provide guidance on FDA approval pathways and regulatory issues under relevant legislation

Benefits

• Flexibility to work full-time, part-time, and during preferred times as part of a fully remote team
• High-quality legal engagements
• The collegiality and camaraderie of highly experienced and talented colleagues to share resources, referrals, and coverage
• The support of an outstanding team of financial, operations, client relations and business development professionals to facilitate the delivery of exceptional, pragmatic, and cost-effective legal services to our clients