Senior Corporate Counsel - Commercial (Brand)

SUMMARY/JOB PURPOSE (Basic purpose of the job):

The Senior Corporate Counsel, Commercial is responsible for providing commercialization legal support, advice and counsel in connection with planning, tactics and strategies undertaken primarily by the Commercial and Medical Affairs departments of the Company.

ESSENTIAL DUTIES/RESPONSIBILITIES:

• Serve as a key legal advisor for various Commercial departments, including Sales, Marketing, and Commercial Strategy, Analytics and Operations, Medical Affairs department, and Public Affairs department in furtherance of their operational responsibilities and consistent with the requirements of the Company's Healthcare Compliance Program.
• Ongoing tracking and evaluation of legal and regulatory developments at the Federal and state levels pertinent to the commercialization of innovative pharmaceuticals, including but not limited to guidance and advisories from FDA, OIG, DOJ, CMS, and other relevant government agencies.
• Assess and advise on legal and regulatory risks related to Commercial activities, including FDA, FTC, Anti-Kickback Statute, False Claims Act, Sunshine Act, and state law considerations.
• Provide strategic counsel to cross-functional teams supporting the commercialization and launch of new products and/or indications, including pre-launch planning, launch execution, and post-launch activities.
• Serve as a core legal member of cross-functional review committees, providing legal review and approval of promotional, educational, and disease awareness materials directed to healthcare professionals, payors, and patients.
• Advice on legal risks associated with product positioning, claims substantiation, fair balance, labeling consistency, off-label risk, pre-approval information exchange, and use of clinical and real-world evidence.
• Draft, review and negotiate a broad range of agreements in support of the Commercial and Medical Affairs departments, including consulting agreements, speaker agreements, advisory board agreements, sponsorships, market research and certain vendor services agreements.
• Advise on compliance with OUS clinical trial recruitment efforts and proactive MSL activities.
• In collaboration with the Healthcare Compliance function and taking into consideration input from operational clients and colleagues, maintain and modify Company policies in a risk-based manner, as necessary to reflect changes and clarifications to applicable laws and regulations, develop associated written guidance, conduct live or web-based training to operational teams.
• Participate in the investigation of complaints and alleged violations of rules, regulations, policies, procedures, and standards of conduct, and coordinate with management in developing/implementing corrective action plans and provide general guidance on such matters.
• Contribute to the development of scalable legal policies and processes to support the Company's growth and evolving business needs.
• Serve as a subject-matter resource on a contracting task force focused on enhancing commercial contracting strategy, including assessment of complex contracting considerations and risk mitigation.
• Handle a broad variety of miscellaneous legal tasks on an as needed basis under direction of managing attorneys.

SUPERVISORY RESPONSIBILITIES:

• No supervisory responsibilities.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• JD degree required and 7 years of relevant experience; or
  • Must be admitted to practice, preferably in California.
• BS/BA degree, preferably in life sciences or a related field.
• Equivalent combination of education and years of experience.

Experience:

• 6-8 years of experience as an attorney in a law firm or in-house legal environment in the biotechnology or pharmaceuticals industry supporting marketed products, or relevant experience supporting product launches and advising on advertising risk.

Knowledge, Skills and Abilities:

• Excellent interpersonal skills with the ability to articulate legal advice in a clear, concise and complete manner, both verbally and in writing.
• As a visible representative of the Legal department with responsibility for the enforcement of Company polices and ethical standards, must exercise strong, positive leadership and influencing skills.
• Must have a record of professional performance and personal integrity reflective of good judgment and the ability to apply legal principles to business facts in a reasonable manner.
• Must be detail-oriented and have strong organizational skills.
• Ability to handle multiple tasks simultaneously and with the ability to re-prioritize on short time frames.
• Acts responsibly and conscientiously.
• Works under pressure to meet specific deadlines.
• Works independently and in a cross-functional team environment.
• Dedicated to quality, reliability, and highest professional standards in all work tasks.
• Must be a self-starter and quick learner.
• Requires strong computer skills.

Work Environment/Physical Demands:

Our office is a modern space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.