Associate Vice President, Assistant General Counsel

Overview

This role involves providing strategic and solutions-oriented legal counsel to a pharmaceutical business unit as brand counsel for its product portfolio within assigned therapeutic areas. The attorney will advise business unit teams—including marketing, medical affairs, product development, and communications—on a variety of legal matters such as FDA labeling and advertising requirements, clinical development and regulatory submissions, healthcare fraud and abuse laws, antitrust and unfair competition law, consumer protection, data rights and privacy, FTC commercial law, and business transactions. Depending on the therapeutic area, additional legal considerations may include sponsored testing, Medicare coverage and reimbursement, and device or digital health regulations.

The position requires collaboration with legal colleagues across departments and affiliates, providing practical counsel in a fast-paced, dynamic, and innovative environment. The role reports to the applicable Business Unit General Counsel.

Responsibilities

• Provide legal counsel and education on FDA labeling and promotional matters
• Advise sales and marketing teams on patient support and other programs in compliance with healthcare fraud and abuse laws
• Educate business partners on legal implications of proposed marketing programs
• Counsel on legal issues related to interactions with third parties such as diagnostics companies and digital health partners
• Participate as a core member of leadership teams responsible for U.S. brands and/or global product strategies
• Draft, review, and advise on contracts related to company assets, including collaborative research agreements
• Advise on data disclosures following clinical development achievements via press releases and medical congresses, ensuring compliance with applicable laws and regulations

Requirements

• Bachelor's degree and Juris Doctor (JD) degree from accredited institutions
• Admission to the bar in at least one U.S. state; eligibility for admission to the Indiana bar under Indiana Admissions Rules
• Minimum of 10 years of relevant legal experience, including at least 4 years in-house within a pharmaceutical or biotechnology company legal department

Preferred Qualifications

• Working knowledge of pharmaceutical marketing laws and regulations as practiced by innovative multinational pharmaceutical manufacturers
• Experience providing product counseling in diabetes, obesity, cardiovascular, or oncology therapeutic areas
• Global mindset with familiarity or experience supporting global pharmaceutical marketing and commercialization outside the United States preferred
• Demonstrated experience with clinical collaborations, the Anti-Kickback Statute, competition law, pricing, reimbursement/access issues including Medicare
• Experience evaluating scientific communications for integrity and compliance with truthful and non-misleading information standards
• Experience assessing sponsored testing programs for compliance
• Ability to manage multiple priorities in a fast-paced, evolving environment
• Strong risk assessment skills to help business colleagues manage legal risks in a highly regulated environment
• Excellent oral and written communication skills, capable of presenting complex information clearly to all management levels including C-suite executives
• Strong analytical, organizational, and issue-spotting abilities
• Demonstrated learning agility, curiosity, and interpersonal skills
• Commitment to teamwork and collaboration within legal and business teams
• Proficiency with technology and enthusiasm for applying technological solutions to improve legal service delivery efficiency
• Proactive identification of opportunities for creative and innovative legal solutions

Compensation & Benefits

• Anticipated salary range: $229,500 - $336,600, dependent on education, experience, skills, and geographic location
• Eligibility for company bonus based on company and individual performance
• Comprehensive benefits package including 401(k), pension, vacation, medical, dental, vision, prescription drug coverage, flexible spending accounts, life insurance, leave of absence benefits, and well-being programs

Location

• United States, Indianapolis preferred
• Remote candidates will be considered if willing to travel to Indianapolis or other locations as needed

Additional Information

• Some travel required within the U.S. and limited international travel
• Bar admission eligibility for Indiana required
• The employer is committed to equal employment opportunity and provides accommodations for individuals with disabilities during the application process