Our client is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy, health policy and evidence-based best practice models.
The Senior Counsel, reporting direct to the US General Commercial Counsel, will provide strategic and commercially-focused legal advice. The ideal candidate has significant experience in sophisticated pharmaceutical transactions, FDA-regulatory, commercial regulatory, advertising and promotions, and pricing/government pricing and reimbursement.
The role will be based at the company's HQ in Richmond, Virginia.
- Advise on legal matters relating to managed care, channel/trade, government price reporting, finance, business analytics, medical, marketing, and sales.
- Counsel business partners on the government pricing regulations, Food Drug & Cosmetic Act, FDA advertising and promotional regulations, Anti-Kickback Statute, False Claims Act, OIG Guidance, anti-trust laws, HIPAA, PhRMA Code, Controlled Substances Act, Prescription Drug Marketing Act, and Sunshine Act.
- Serve on pricing committee approving price/rebate proposals.
- Draft and execute managed market and rebate contracts.
- Analyze service fee arrangements for bona fide services and fair market value.
- Advise senior business leaders on distribution strategy for specialty product.
- Negotiate and execute distribution agreements.
- Provide legal review on promotional and medical review committees, including for boxed warning product.
- Advise hub and co-pay programs on anti-kickback issues and program rules.
- Conduct investigations and internal analysis of compliance issues.
- Provide timely, well-reasoned and practical legal advice to business units and other senior management.
Role Qualifications, Skills and Key Competencies
- 7-10 years of experience in sophisticated pharmaceutical transactions, FDA-regulatory, commercial regulatory, advertising and promotions, and pricing/government pricing and reimbursement.
- Ideal candidate has a background in a leading law firm, and some experience in-house.
- Strategic thinker and decisive, trusted advisor with strong attention to detail and ability to work in a fast-paced environment.
- Executive presence.
- Ability to successfully manage and meet deadlines within a changing, fast-paced environment while remaining cool under pressure.
- Pragmatic business acumen.
- Collaborative team player who works well both independently and in a team environment.
- Ability to make decisions and operate independently with respect to complex issues and assessment of risk.
- Mature judgment and gravitas with the ability to build relationships and engender confidence across the company, including senior management and other legal team members.
- Excellent verbal, written and interpersonal skills and an ability to convey complex legal principles clearly and concisely.
- Self-starter, with entrepreneurial approach.
The SR Group (US), Inc. is acting as an Employment Agency in relation to this vacancy.