Director, Legal – Commercial and Medical Review

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $250k - $275k / year

⏰ Full Time

🔴 Lead

⚖️ Legal Counsel / General Counsel

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Notified

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2004

📣 Marketing

☁️ SaaS

🤝 B2B

Marketing • SaaS • B2B

Notified is a B2B SaaS company that provides media monitoring and communications software for PR and marketing teams. It helps organizations track media coverage, social mentions, and influencer activity; measure campaign performance and audience reach; and manage communications and stakeholder engagement across earned, owned, and social channels. Notified’s platform is used by enterprises and agencies to centralize insights, reporting, and workflows for public relations and corporate communications.

📋 Description

• Serve as Legal representative on the Promotional Review Committee and Medical Review Committee • Review HCP-facing, patient-facing, medical, and corporate materials for compliance with FDA, FTC, and applicable industry requirements • Provide legal advice across pre-launch and launch activities while balancing legal risk with business objectives • Review patient education, disease awareness, website, digital content, and patient support program communications • Evaluate claims for substantiation, fair balance, and net impression, including comparative, subgroup, and pharmacokinetic claims • Advise on pre-approval communications, scientific exchange, disease awareness, medical education, congress activity, and investor/corporate messaging boundaries • Review non-promotional and medical affairs materials, unsolicited-request responses, payor and formulary communications, and digital/social media content • Guide compliant business activities involving disease education, HCP engagement, and patient-facing materials • Support corporate legal matters and business development initiatives as needed • Help design review standards and procedures for planned launch and commercialization • Report to the VP, Commercial Legal and interact cross-functionally with Commercial, Medical Affairs, Regulatory, Legal, and Compliance

🎯 Requirements

• JD from an accredited law school • 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, promotion regulations, and commercial legal requirements • Knowledge of product launch planning and commercialization activities • Experience reviewing HCP and patient materials • Experience 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 • Strong business judgment and practical, solutions-oriented risk management • Ability to balance legal risk and apply mitigation strategies • Ability to influence and advise in a matrixed environment • Excellent communication skills and ability to translate complex legal and regulatory concepts into actionable business guidance • Strong cross-functional collaboration and relationship-building skills • Ability to operate effectively in a fast-paced, resource-constrained environment • High degree of autonomy, accountability, and execution focus • Up to 10% travel, frequently outside the local area and overnight

🏖️ Benefits

• Medical insurance • Dental insurance • Vision insurance • Time off • 401K • Participation in Mineralys incentive plans contingent on achievement of personal and company performance

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