Director, Advertising and Promotional Integrity

Work 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.

Rocket Pharma is seeking an experienced and highly motivated Director, Advertising and Promotional Integrity (AdPromo), who enjoys a fast paced, dynamic work environment at the forefront of innovation. This role is responsible for providing strategic and tactical management and oversight for promotional communications for Rocket products as well as promotional material are in applicable FDA regulations, company policies, and applicable Industry Guidelines for the advertising and promotion of prescription biologics. This role reports into the Head of Regulatory Affairs.

• Provide regulatory leadership and guidance to cross-functional teams during the development, review and approval of product labeling and advertising materials.
• In collaboration with Medical, Legal and Commercial, provides Regulatory leadership and oversight to ensure that regulatory requirements are integrated in product and disease-state communications.
• Provide a leadership role on the review committee (RC) by providing regulatory guidance on promotional labeling and advertising materials.
• Develops solutions to complex promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively identifying, escalating and managing business risks.
• Work collaboratively with Compliance and Legal to ensure that materials approved are used within the intended guidelines.
• Review content and format of documents, assuring compliance with corporate policies, federal regulations and guidelines, and product development objectives.
• Ensures that changes in product labeling are carried into promotional materials in accordance with company procedures and regulatory requirements
• Participate in training of sales and marketing personnel on promotional, labeling and advertising regulations.
• Serve as FDA liaison for matters related to the advertising and promotion of assigned products.
• Serves as a subject matter expert on relevant regulations, stays abreast of changes in the regulatory environment, and assesses impact of changes on business and product development programs.
• Proactively manages critical issues, taking leadership for regulatory adpromo contribution.
• Support the development of relevant policies, processes, and SOPs.

• MS degree and 10 years pharmaceutical industry experience with direct experience in implementation of promotional labeling and advertising regulations
• We encourage applicants with strong expertise in cell and gene therapy, particularly those with a PharmD or PhD, to apply. This skill set and educational background may outweigh the requirement for a specific number of years of experience.

• In-depth understanding of clinical study design and statistical analyses in assessment of promotional claims.
• Extensive understanding of labeling regulations and global promotional review
• Strong scientific foundation.
• Practical understanding, interpretation, and application of relevant FDA guidelines and regulations.
• Excellent verbal and written skills; able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates issues to internal and external stakeholders, including Senior Management.
• Ability to think creatively and develop creative solutions.
• Ability to prioritize and handle multiple projects simultaneously.
• Sense of urgency and perseverance to achieve bringing curative therapies to patients.

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.