What are the responsibilities and job description for the Vice President, Associate General Counsel position at NPAworldwide?
Job Description
Salary Min : $ 300000
Salary Max : $ 380000
Currency Type : USD
- Provide strategic, operational, and tactical legal counsel and business advice related to the development and commercialization of Invivyds product(s) and product candidate(s).
- Advise clients on FDA (and global regulatory authority) regulatory matters and compliance with laws, rules, regulations, guidance, and industry standards that arise throughout a product lifecycle, including in the areas of product development, regulatory submissions, advertising and promotion, and drug safety.
- Provide legal counsel on healthcare laws, including the Federal Anti-Kickback Statute, FDCA, False Claims Act, PhRMA Code, FTC, HIPAA, CAN-SPAM, state laws on physician gifts/meals, Sunshine Act, state price transparency reporting, product liability statutes, and related healthcare legal obligations.
- Have a Juris Doctor (J.D.) from an ABA-accredited law school; be a licensed attorney in at least one U.S. state and in good standing in all states where you are licensed; and have the ability to obtain CT in-house counsel registration.
- A minimum of 10 years of relevant experience with a pharmaceutical/biopharma company (can be combined with relevant experience at a law firm) providing relevant life sciences advice, counsel, and support to pharma/biopharma companies.
- Demonstrated expertise in relevant federal and state laws, regulations, rules, and guidance as well as industry codes and principles impacting pharmaceutical manufacturers, including but not limited to applicable law concerning drug labeling, advertising and promotion, scientific exchange, market access communications, government reimbursement, and product liability.
- Demonstrated experience supporting regulatory and commercialization teams including providing legal counsel on Medical, Legal, Regulatory review committee, development and implementation of promotional activities, market access communications, drug labeling, scientific exchange.
- Product launch experience strongly preferred.
- Buy and bill experience a plus.
- Experience supporting regulatory affairs and drug safety in pharmaceutical development and ongoing obligations.
- Knowledge of enforcement landscape, including relevant industry litigation, settlements, and corporate integrity agreement obligations.
- Litigation experience a plus.
- Provide strategic, operational, and tactical legal counsel and business advice related to the development and commercialization of Invivyds product(s) and product candidate(s).
- Advise clients on FDA (and global regulatory authority) regulatory matters and compliance with laws, rules, regulations, guidance, and industry standards that arise throughout a product lifecycle, including in the areas of product development, regulatory submissions, advertising and promotion, and drug safety.
- Provide legal counsel on healthcare laws, including the Federal Anti-Kickback Statute, FDCA, False Claims Act, PhRMA Code, FTC, HIPAA, CAN-SPAM, state laws on physician gifts/meals, Sunshine Act, state price transparency reporting, product liability statutes, and related healthcare legal obligations.
Salary Min : $ 300000
Salary Max : $ 380000
Currency Type : USD
Salary : $300,000 - $380,000