Summary: Responsible for legal support for pharmaceutical and medical device operations within US organization
Review and advise on advertising and promotional, sales training, market access, medical affairs, and related materials that deal with any of the company’s products and business interests. Provide strategic advice on commercial initiatives relating to the company’s products.
Provide privacy-related legal advice and support on commercial, R&D, information technology, and other US privacy issues and initiatives including application of HIPAA and other US and global privacy laws, including GDPR. Provide US legal input into global policies and practices relating to privacy and data protection. Advise on California Consumer Privacy Act and other state privacy laws.
Negotiate transactions and prepare various contracts and commercial agreements utilized by the company in conducting its business operations (including Master Services Agreements, Consulting Agreements, Managed Care Agreements, Confidentiality Agreements, and Agency Agreements)
Advise on FDA regulatory matters and compliance with laws, regulations, industry standards and company policies that arise throughout the product lifecycle, including in the areas of product development, advertising and promotion, research, and quality.
Advise and improve on the design and implementation of Company policies and procedures, including relating to data protection, cybersecurity, and data breach incident response.
Other job responsibilities as assigned.
Requirements: J.D. from an accredited law school, admission to and current good standing with the bar in New Jersey or eligible for in-house counsel license in New Jersey Minimum 5 years’ relevant legal experience. Experience in pharmaceutical or medical device industry preferred.
Knowledge and experience in one or more of the following areas:
Data Protection and Privacy, including HIPAA, GDPR, California Consumer Privacy Act, particularly as applied to medical and employee data
Review and approval of pharmaceutical and/or medical device advertising and promotional, sales training, and related materials, as well as providing legal advice to brand teams on commercial initiatives
FDA regulatory matters and compliance with laws, regulations, industry standards and company policies that arise throughout the product lifecycle, including in the areas of product development, advertising and promotion, research, and quality.
Experience in drafting various types of contracts and agreements strongly preferred (e.g., Master Services Agreements, Consulting Agreements, Confidential Disclosure Agreements)
Knowledge of health care laws and industry guidance (including the the Federal Anti-Kickback Statute, False Claims Act, state fraud and abuse laws, PhRMA Code and AdvaMed Code of Ethics) preferred.
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