Quality Engineering Program Manager, Post Market
Medtronic
Senior Counsel, Product
Nuvalent, Inc.
full-time
Posted on:
Origin: • 🇺🇸 United States • Massachusetts
Visit company websiteJob Level
Senior
About the role
- With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer.
- Reporting to the Deputy General Counsel, Commercial and Compliance, the Senior Counsel, Product will advise on strategic and tactical issues related to development and commercialization of prescription drug products.
- Advise on healthcare fraud and abuse laws, FDA regulations, drug pricing and transparency laws, access and reimbursement, privacy laws, and patient support programs.
- Act as brand lawyer and reviewer on Promotional Materials Review Committee and Medical Review Committee.
- Support cross-functional compliance initiatives and commercialization-related contracts.
- Serve as legal advisor to marketing, medical affairs, market access, sales; review advertising, promotional, medical, and market access materials.
- Provide legal advisement on sales and marketing strategy, market access activities, patient support programs, media campaigns, and interactions with patients and advocacy organizations.
- Assist in development of enterprise-wide compliance program.
Requirements
- 7+ years of recent relevant legal experience in product support of biotech/pharma, with a strong preference for experience with launching a product in the U.S. market and 3+ years in-house pharmaceutical or biotech oncology experience
- Juris Doctor from an accredited law school; active membership and in good standing in a state bar and either admitted to the Massachusetts bar or eligible for admission to the Massachusetts bar as in-house counsel
- Significant knowledge of enforcement trends, the Federal Food, Drug and Cosmetic Act and related regulations, the False Claims Act, and laws related to fraud and abuse in the life science/biotech/pharma industries
- Experience with pharmaceutical/biotech commercial contracting preferred
- Ability to travel as required to support business activities.
