Description:
We are seeking a Senior Director, Commercial Counsel, to support our Legal and Compliance team. The Senior Director, Commercial Counsel, will be responsible for supporting the commercial team and future product launches.What You'll Do:
As a Senior Director, Commercial Counsel, you will play a key role in supporting our Legal and Compliance operations:
- Participating in all aspects of legal operations to support continued corporate growth, including pharmaceutical industry compliance, corporate governance and contract negotiation
- Advising the business on pharmaceutical compliance, regulations, industry standards and company policies that arise throughout the product launch and lifecycle
- Provide legal review and counsel for promotional materials, including TV, digital, and print advertising, in coordination with Regulatory and Medical Affairs
- Ensure promotional claims comply with FDA regulations, the Federal Food, Drug, and Cosmetic Act, and FTC standards
- Counsel on interactions with healthcare professionals and patients in accordance with industry codes (e.g., PhRMA Code, OIG Guidance)
- Providing legal advice and business counsel on sales and marketing tactics and strategies
- Responsible for policy development and implementation
- Responsible for compliance training and administration
- Conducting internal investigations
- Ensuring contractual compliance with applicable regulations and statutes
- Overseeing and managing a wide variety of agreements, including, service agreements, clinical trial agreements, confidentiality agreements, consulting agreements, and other commercial and R&D agreements
- Assisting with corporate matters and projects, employment law matters, insurance procurement, litigation oversight and other duties and responsibilities as assigned
- Coordinating and managing legal matters handled by outside counsel
- Partnering with executive, research, operations, finance and human resources colleagues on various matters
- Experience with privacy laws and regulations
Secondary Functions:
Experience with privacy laws and regulations
Required Experience and Education:
- J.D. Degree and at least 5+ years practicing law at a major law firm and/or pharmaceutical or biotechnology company with significant relevant pharmaceutical compliance and corporate experience
- Understanding of pharmaceutical regulatory and compliance environment and working knowledge of general corporate matters
- Exceptional business acumen and judgment
- Demonstrated expertise negotiating and drafting complex agreements
- Experience designing and implementing policies and processes pertaining to pharmaceutical regulations
- Juris Doctorate, admission to at least one state bar and in-house qualification
Preferred Experience and Education:
- Intermediate Excel skills.
- Professional writing experience.
Competencies:
- Organization-focused and ability to interact with all levels of the organization.
- Outstanding interpersonal, written and oral communication skills
- Complex project management skills, including the ability to multi-task across high-volume projects, prioritize and manage timelines effectively in a responsive and professional manner
