Partner, FDA-Commercialization/Regulatory

July 17

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Briefly™️

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Building the new internet for the marketing industry

marketing • technology • production • design • branding

11 - 50

Description

• Outside GC is a virtual law firm offering an innovative approach to legal services. • Team of senior business lawyers providing outstanding corporate and IP legal services to companies and non-profit organizations. • Clients develop a working relationship with one lawyer and have access to the whole team. • Focus on diversity, equity, and inclusion is integral to hiring exceptional people and creating enduring businesses.

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 and 3+ years of law firm training. • J.D. from a nationally accredited law school • State bar membership in state where reside/practice • Advising drug manufacturers on policy developments and enforcement trends in advertising and promotion. • Counseling medical device and technology firms on FDA digital health policies and regulation of mobile medical applications. • Evaluating the effectiveness of FDA and healthcare compliance programs. • Updating policies related to communication of scientific and medical information. • Assisting in obtaining priority review vouchers and modifying post-marketing studies. • Providing 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.