Senior Director/ Exec Director, Regulatory and Compliance Counsel

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Job description

Job Summary:

MEI is seeking an experienced attorney to serve as (Senior or Executive Director), Regulatory and Compliance Counsel, reporting to our Chief Compliance Officer. This role will be responsible for providing legal advice and counsel in support of our investigational products and brand planning activities in preparation for commercial launch. This attorney will provide legal advice across the product portfolio, in areas such as FDA regulations, Anti-kickback Statute, PhRMA Code and other industry guidance documents. clinical development activities, product labeling, scientific exchange, publications, medical affairs activities and launch preparedness. This role will serve as the legal function representative on the review team for medical materials, unbranded campaigns and ultimately promotional materials.

Role and Responsibilities (include but not limited to):

The SD or ED, Regulatory and Compliance Counsel will be responsible for providing proactive advice and support across brand functions (e.g. Medical Affairs, Marketing, Regulatory, Sales). Specific Activities include:

• Partner and collaborate with other departments and functions (e.g. Contracting, Privacy, HR, IT)
• Review and approval of various brand activities and tactics
• Serve on cross functional team responsible for product labeling
• Serve on cross functional review teams advising on medical materials and promotional materials
• Serve on other cross functional teams and governance bodies as assigned
• Prepare and Conduct training on a variety of legal and compliance topics
• Assist in the preparation of organization and leadership communications
• Potential management of future team members
• Other activities as assigned.

Qualifications:

• A Minimum of 10 years of law practice, at least 7 years of experience in the pharmaceutical industry
• Direct experience advising on the Food Drug and Cosmetic Act and associated regulations, Anti-Kickback Statute, FCPA, Managed Markets and Pricing issues
• Excellent oral and written communication skills
• Ability to present complex information accurately and concisely to all levels of management
• Excellent presentation/ skills
• Ability to develop/create engaging training
• Ability to contribute individually as well as lead cross functionally

Job Requirements and Education:

• Bachelor's Degree
• Juris Doctorate Degree
• Active license to practice law- admitted to the bar in at least one of the 50 states and eligible for in-house counsel registration in California