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Form of workWork at ROCKET PHARMA and help cure rare diseases!
Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.
The Brand Counsel position is responsible for providing legal, regulatory and healthcare compliance counsel for our gene therapy franchises. This position will oversee the gene therapy franchises and provide substantive advice to cross-functional departments including Commercial, Medical Affairs, and Regulatory Affairs. This position provides counsel concerning a broad range of legal, regulatory and compliance issues, including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code and competition law in connection with product labeling, promotional and non-promotional activities, marketing strategies, sales compensation, government reimbursement, and interactions with healthcare professionals.
- Provide focused legal support, in collaboration with other attorneys, for global commercial and late-stage development products
- Serve as legal advisor/core brand attorney to commercial, medical affairs, market access, distribution and development teams for late-stage products and marketed products
- Lead assigned cross-functional legal initiatives and serve as lead lawyer on cross-functional commercial teams including without limitation, brand team, promotional and other material review committees and medical drug information
- Collaborate with R&D, IP, Commercial colleagues involved with late stage clinical and marketed products with responsibility for ensuring an aligned approach across multiple products
- Review business materials (including brand plans, promotions, medical plans, training documents) requiring legal input and advising internal clients, partners and stakeholders on compliant strategies, plans and tactics;
- Advise cross functional teams including clinical, product development, regulatory, medical affairs, and other clients on FDA regulatory submissions, label negotiations and privacy and data use.
- Counsel on appropriate relationships with a variety of external parties, including healthcare professionals, patients, academic institutions, and payors.
- Work collaboratively with Compliance colleagues to develop and implement training to internal clients, partners and stakeholders on key policies, procedures, practices and requirements for healthcare and related legal compliance and educate clients and partners about current enforcement trends.
- JD and admittance to a state bar association, preferably NY/NJ
- 12+ years of experience in the pharmaceutical industry, in-house experience preferred
- Experience overseeing/implementing Healthcare Compliance programs
- Experience with pre-commercial and commercial stage
A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.
