Senior Counsel

This is a fully remote position, open to applicants in Maryland.

📋 Description

• Offer legal assistance for intricate U.S. and international legal, regulatory, and compliance issues.

• Provide advice on the review of marketing, sales, medical, and training materials.

• Deliver strategic legal counsel and solutions to commercial business teams.

• Guide business units on federal and state healthcare legislation, regulations, and industry standards.

• Advise on both internal and external communication strategies.

• Offer guidance on sales and marketing, market access, patient advocacy, patient services, medical information, fee-for-service agreements, drug pricing, data privacy, social media, endorsers, drug labeling, strategic planning, competitive matters, and nonprofit interactions.

• Assist Government Affairs and collaborate with external legal counsel.

• Represent the Legal department in cross-functional committees and teams.

• Collaborate on intricate agreements.

• Support regulatory, medical affairs, and product development teams.

• Educate and train business and cross-functional stakeholders.

• Engage in departmental initiatives and enhance Legal operations.

• Contribute to internal policies, training, and corporate governance initiatives.

• Participate in mergers and acquisitions, licensing, and other partnership activities, including risk assessment and due diligence.

• Undertake additional responsibilities as assigned.

⛳️ Requirements

• Juris Doctor degree from an ABA-accredited institution.

• Licensed to practice law in at least one U.S. state and in good standing.

• 5–7 years of experience in a law firm and/or legal department within the pharmaceutical or biotechnology sectors.

• A minimum of 2 years of in-house experience in the biotech and/or pharmaceutical industry.

• Familiarity with pharmaceutical legal matters, including regulatory processes for prescription and OTC medications, anti-kickback laws, fraud and abuse regulations, anti-bribery and anti-corruption statutes, and antitrust legislation.

• Practical knowledge of the global regulatory landscape.

• Comprehensive understanding of pharmaceutical industry intellectual property, manufacturing, research and development, regulatory, and commercial aspects.

• Excellent analytical, problem-solving, negotiation, communication, oral, written, and presentation skills.

• Ability to deliver practical legal advice in a fast-paced, dynamic, and complex environment.

• Capability to work autonomously, take initiative, and manage priorities, workloads, and risks effectively.

• Proficiency in establishing and maintaining effective working relationships.

• Experience in a matrix environment is an advantage.

• Experience in supporting products outside the U.S. is highly desirable.

🏝️ Benefits

• Comprehensive benefits package.

• Merit-based salary increases.

• Annual bonus opportunities.

• Long-term incentives in the form of stock options.

• Reasonable accommodations for individuals with disabilities.

• Employee health and wellness initiatives.