Senior Counsel, Commercial and Compliance

Job Description

Assume the role of the lead legal advisor for both the Commercial and Medical Affairs divisions. Offer strategic guidance throughout the pre-launch and launch phases, adeptly navigating legal considerations while aligning with business goals. Enhance commercial readiness, encompassing marketing strategies, market access, patient support services, and distribution frameworks. Compose, scrutinize, and negotiate a diverse array of commercial contracts, including those related to vendors, patient assistance initiatives, speaker engagements, distribution channels, and market entry. Steer the legal assessment of marketing and medical resources via MLR/PRC procedures. Offer counsel on engagements with healthcare professionals, patients, payers, specialized pharmacies, and governmental bodies. Bolster commercial and medical endeavors, such as speaker programs, advisory councils, sponsorships, grants, medical data inquiries, and scholarly interchanges. Deliver advice on adhering to regulatory mandates in business functions like educational outreach, healthcare provider collaborations, advisory panels, and patient-focused materials. Spearhead the creation and roll-out of a versatile healthcare compliance blueprint, tailored to pertinent regulations and industry norms, to foster successful commercialization. Institute protocols, operational guidelines, educational initiatives, and oversight mechanisms. Put in place transparent reporting systems for aggregate spending. Anticipate legal and compliance concerns, formulating practical solutions for mitigation. Stay abreast of evolving healthcare statutes, regulations, and sector developments. Convey clear, business-centric advice to upper management. Aid in corporate legal matters and business expansion projects as needed. Competently oversee external legal support. Contribute to the development of a robust, cooperative legal department.

Qualifications

1. Possession of a J.D. degree from a recognized law institution, along with active bar admission in at least one U.S. jurisdiction. 2. Demonstrated experience of 8–12+ years in the legal field within the biotech/pharmaceutical sectors, with a preference for in-house roles. 3. Verifiable success in aiding commercial development and product introductions. 4. Comprehensive understanding of healthcare laws and compliance standards, including FDA regulations, OIG guidelines, PhRMA Code, Anti-Kickback statutes, False Claims Act, and Sunshine Act. 5. Extensive involvement with MLR/PRC reviews, promotional regulations, and the establishment of compliance programs. 6. Proficiency in drafting and negotiating intricate commercial agreements. 7. Capacity to thrive in a dynamic, rapidly changing environment characterized by significant accountability.

Benefits

- Medical - Dental - Vision - Time off - 401K - Participating in Mineralys incentive plans contingent on achievement of personal and company performance